Pharmacokinetic And Pharmacodynamic Study Of A Single-Dose Of PF-04950615 (RN316) In Combination With Atorvastatin
2018年1月31日 更新者：Pfizer
A Phase 1 Study Evaluating The Pharmacokinetics And Pharmacodynamics Of Rn316 In Combination With Atorvastatin In Hypercholesterolemic Subjects
The primary objective of this study is to evaluate the pharmacokinetics and pharmacodynamics of a single dose of PF-04950615 (RN316) in volunteers on stable doses of atorvastatin.
PF-04950615 (RN316) is an investigational drug that is currently being studies as a cholesterol lowering therapy.
調査の概要
研究の種類
介入
入学 (実際)
25
段階
- フェーズ 1
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Arizona
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Peoria、Arizona、アメリカ、85381
- Premier Research Group, Limited
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Phoenix、Arizona、アメリカ、85027
- Premier Research Group Limited
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Phoenix、Arizona、アメリカ、85013
- Dedicated Phase 1, Inc.
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Kansas
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Overland Park、Kansas、アメリカ、66212
- Vince and Associates Clinical Research
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Overland Park、Kansas、アメリカ、66211
- Vince and Associates Clinical Research
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～80年 (大人、高齢者)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
Inclusion Criteria:
- On stable doses of atorvastatin (40 mg daily) for 45 days prior to Day 1.
- BMI 18.5 to 40 kg/m2 inclusive, and body weight equal or lower than 150 kg.
Exclusion Criteria:
- History of a cardiovascular event (e.g., MI ) during the past year.
- Poorly controlled Type 1 or Type 2 Diabetes mellitus (definition: uncontrolled diabetes is defined as HBIAc >9%).
- Poorly controlled hypertension (uncontrolled hypertension is defined as a systolic blood pressure greater than 140 mm Hg or a diastolic blood pressure greater than 90 mm Hg, even with treatment). Subjects who have hypertension and are controlled on stable dosages of anti-hypertensive medications can be included.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：PF-04950615 (RN316)
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RN316 10 mg/ml vial sd.
Infusion based on weight Infusion duration = 60 minutes.
他の名前：
RN316 10 mg/ml vial sd.
Infusion based on weight Infusion duration = 60 minutes.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-04950615
時間枠：0 (pre-dose on Day 4), 1, 4, 8 and 12 hours (hrs) post intravenous PF-04950615 (RN316) dose, pre atorvastatin dose on Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
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0 (pre-dose on Day 4), 1, 4, 8 and 12 hours (hrs) post intravenous PF-04950615 (RN316) dose, pre atorvastatin dose on Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
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Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04950615
時間枠：0 (pre-dose on Day 4), 1, 4, 8 and 12 hours (hrs) post intravenous PF-04950615 (RN316) dose, pre atorvastatin dose on Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
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0 (pre-dose on Day 4), 1, 4, 8 and 12 hours (hrs) post intravenous PF-04950615 (RN316) dose, pre atorvastatin dose on Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
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Maximum Observed Plasma Concentration (Cmax) of PF-04950615
時間枠：0 (pre-dose on Day 4), 1, 4, 8 and 12 hours (hrs) post intravenous PF-04950615 (RN316) dose, pre atorvastatin dose on Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
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0 (pre-dose on Day 4), 1, 4, 8 and 12 hours (hrs) post intravenous PF-04950615 (RN316) dose, pre atorvastatin dose on Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
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Plasma Decay Half-Life (t1/2) of PF-04950615
時間枠：0 (pre-dose on Day 4), 1, 4, 8 and 12 hours (hrs) post intravenous PF-04950615 (RN316) dose, pre atorvastatin dose on Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
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Plasma decay half-life is the time measured for the plasma concentration of PF-04950615 to decrease by one half.
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0 (pre-dose on Day 4), 1, 4, 8 and 12 hours (hrs) post intravenous PF-04950615 (RN316) dose, pre atorvastatin dose on Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
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Systemic Clearance (CL) of PF-04950615
時間枠：0 (pre-dose on Day 4), 1, 4, 8 and 12 hours (hrs) post intravenous PF-04950615 (RN316) dose, pre atorvastatin dose on Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
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CL is a quantitative measure of the rate at which a drug substance is removed from the body.
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0 (pre-dose on Day 4), 1, 4, 8 and 12 hours (hrs) post intravenous PF-04950615 (RN316) dose, pre atorvastatin dose on Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
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Volume of Distribution at Steady State (Vss) of PF-04950615
時間枠：0 (pre-dose on Day 4), 1, 4, 8 and 12 hours (hrs) post intravenous PF-04950615 (RN316) dose, pre atorvastatin dose on Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
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Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.
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0 (pre-dose on Day 4), 1, 4, 8 and 12 hours (hrs) post intravenous PF-04950615 (RN316) dose, pre atorvastatin dose on Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
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Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC0-inf) of PF-04950615
時間枠：0 (pre-dose on Day 4), 1, 4, 8 and 12 hours (hrs) post intravenous PF-04950615 (RN316) dose, pre atorvastatin dose on Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
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0 (pre-dose on Day 4), 1, 4, 8 and 12 hours (hrs) post intravenous PF-04950615 (RN316) dose, pre atorvastatin dose on Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
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Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Atorvastatin
時間枠：0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 and 12 hrs post-dose on Day 4
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AUCtau was the AUC from time 0 to the end of the dosing interval, where the dosing interval was 12 hours.
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0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 and 12 hrs post-dose on Day 4
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Time to Reach Maximum Observed Plasma Concentration (Tmax) of Atorvastatin
時間枠：0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 and 12 hrs post-dose on Day 4, pre atorvastatin dose on Day 5, 6 and 7
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0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 and 12 hrs post-dose on Day 4, pre atorvastatin dose on Day 5, 6 and 7
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Maximum Observed Plasma Concentration (Cmax) of Atorvastatin
時間枠：0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 and 12 hrs post-dose on Day 4, pre atorvastatin dose on Day 5, 6 and 7
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0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 and 12 hrs post-dose on Day 4, pre atorvastatin dose on Day 5, 6 and 7
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Plasma Decay Half-Life (t1/2) of Atorvastatin
時間枠：0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 and 12 hrs post-dose on Day 4, pre atorvastatin dose on Day 5, 6 and 7
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Plasma decay half-life is the time measured for the plasma concentration of atorvastatin to decrease by one half.
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0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 and 12 hrs post-dose on Day 4, pre atorvastatin dose on Day 5, 6 and 7
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Apparent Oral Clearance (CL/F) of Atorvastatin
時間枠：0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 and 12 hrs post-dose on Day 4
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Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.
Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.
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0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 and 12 hrs post-dose on Day 4
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Apparent Volume of Distribution (Vz/F) of Atorvastatin
時間枠：0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 and 12 hrs post-dose on Day 4
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Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.
Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
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0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 and 12 hrs post-dose on Day 4
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
時間枠：Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64
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Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 administration.
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Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64
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Change From Baseline in Fasting Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
時間枠：Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64
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Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 administration.
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Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64
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Change From Baseline in Fasting Non High-density Lipoprotein-Cholesterol (Non-HDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
時間枠：Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64
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Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 administration.
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Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64
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Change From Baseline in Fasting Triglycerides at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
時間枠：Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64
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Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 administration.
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Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64
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Change From Baseline in Fasting Apolipoprotein B (ApoB) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
時間枠：Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64
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Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 administration.
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Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64
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Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
時間枠：Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64
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Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 (RN316) administration.
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Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64
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Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
時間枠：Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64
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Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 administration.
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Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64
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Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
時間枠：Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64
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Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 administration.
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Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64
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Percent Change From Baseline in Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
時間枠：Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64
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Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 administration.
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Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64
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Percent Change From Baseline in Fasting Non-High-density Lipoprotein-cholesterol (Non-HDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
時間枠：Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64
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Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 administration.
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Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64
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Percent Change From Baseline in Fasting Triglycerides Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
時間枠：Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64
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Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 (RN316) administration.
|
Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64
|
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Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
時間枠：Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64
|
Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 (RN316) administration.
|
Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64
|
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Percent Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
時間枠：Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64
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Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 administration.
|
Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64
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Percent Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
時間枠：Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64
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Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 (RN316) administration.
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Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64
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Duration of Low Density Lipoprotein (LDL) Lowering Effects
時間枠：Day 4 to Day 64
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In this outcome measure duration of the lipid-lowering effects was reported.
Lipid lowering was defined as decrease in LDL-C levels by greater than or equal to 15 percent.
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Day 4 to Day 64
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Number of Participants With Toxicity or Intolerable Dose Criteria
時間枠：Day 1 up to Day 64
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Toxicity criteria included any of the following: serious adverse event; increased liver transaminases (alanine aminotransferase [ALT] or aspartate aminotransferase [AST]: increased to greater than [>] 5*upper limit of normal reference range [ULN]); increased bilirubin (in absence of ALT or AST elevations, common terminology criteria for adverse events [CTCAE] greater than or equal to [>=] Grade 2); pancreatitis, increased serum creatinine (CTCAE >= Grade 2); creatine kinase, hyperglycemia or hypoglycemia, diarrhea or enteritis or nausea (CTCAE >= Grade 3); decreased platelet count (less than [<] 100000 per microliter); prolongation of QT interval with Fridericia's Correction (QTcF) (QTcF >500 millisecond [msec] [CTCAE >= Grade 3] or increase from baseline of >=60 msec) and other considered appropriate by investigator.
CTCAE Grade 4.0: Grade 1= mild; Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening consequences and Grade 5= death related to adverse event.
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Day 1 up to Day 64
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Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
時間枠：Day 1 up to Day 64
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An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Treatment-emergent are events between first dose of study drug and up to 64 days that were absent before treatment or that worsened relative to pretreatment state.
Adverse events included both serious and non-serious adverse events.
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Day 1 up to Day 64
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Number of Participants With Treatment-Emergent Adverse Events by Severity
時間枠：Day 1 up to Day 64
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An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Treatment-emergent are events between first dose of study drug and up to 64 days that were absent before treatment or that worsened relative to pretreatment state.
AEs were assessed for severity by CTCAE Grade 4.0: Grade 1= mild; Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening consequences and Grade 5= death related to adverse event.
Categories with at least 1 participant were reported
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Day 1 up to Day 64
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Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
時間枠：Day 1 up to Day 64
|
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug.
SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
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Day 1 up to Day 64
|
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Number of Participants With Systemic Treatment Emergent Adverse Events Identified by Physical Examination
時間枠：Day 1 up to Day 64
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An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Treatment-emergent are events between first dose of study drug and up to 64 days that were absent before treatment or that worsened relative to pretreatment state.
Complete physical examination was conducted to assess skin, ears, throat, cardiac, respiratory, gastrointestinal, and musculoskeletal systems for systemic AEs.
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Day 1 up to Day 64
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Number of Participants With Systemic Treatment Emergent Adverse Events Identified by Vital Signs
時間枠：Day 1 up to Day 64
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An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Treatment-emergent are events between first dose of study drug and up to 64 days that were absent before treatment or that worsened relative to pretreatment state.
Vital sign parameters body temperature, blood pressure and heart rate were assessed to identify systemic adverse events.
AEs (all causalities), treatment related AEs and CTCAE severity grades for AEs were reported.
CTCAE Grade 4.0: Grade 1= mild; Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening consequences and Grade 5= death related to adverse event.
Categories with at least 1 participant were reported
|
Day 1 up to Day 64
|
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Number of Participants With Systemic Treatment Emergent Adverse Events Identified by Electrocardiogram (ECG) Parameters
時間枠：Day 1 up to Day 64
|
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Treatment-emergent are events between first dose of study drug and up to 64 days that were absent before treatment or that worsened relative to pretreatment state.
ECG parameters RR interval, PR interval, QRS complex, QT interval, [Bazett's Correction], QTcF interval [Fridericia's Correction] were assessed to identify systemic AEs.
AEs (all causalities), treatment related AEs and CTCAE severity grades for AEs were reported.
CTCAE Grade 4.0: Grade 1= mild; Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening consequences and Grade 5= death related to adverse event.
Categories with at least 1 participant were reported.
|
Day 1 up to Day 64
|
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Number of Participants With Systemic Treatment Emergent Adverse Events Identified by Laboratory Parameters
時間枠：Day 1 up to Day 64
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Laboratory parameters alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, gamma glutamyl transferase, lactate dehydrogenase, albumin, hemoglobin, protein, amylase, creatine kinase, lipase, basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets, white blood cells, bicarbonate, chloride, potassium, sodium, bilirubin, blood urea nitrogen, c-reactive protein , calcium, creatinine, direct bilirubin, glucose, magnesium, phosphate, uric acid, hematocrit, partial thromboplastin time , prothrombin time, red blood cells , urine pH, urine specific gravity were assessed to identify systemic AEs.
AEs (all causalities), treatment related AEs and CTCAE severity grades for AEs were reported.
Same participant may be reported in more than 1 CTCAE severity grade.
Categories with at least 1 participant were reported.
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Day 1 up to Day 64
|
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Number of Participants With Positive Anti-drug Antibodies (ADA)
時間枠：Day 1 up to Day 64
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Human serum ADA samples of participants who received PF-04950615 (RN316) were analyzed for the presence of anti-PF-04950615 (RN316) antibodies.
Results with titer value >=4.32 nanogram per milliliter of anti-PF-04950615 antibodies were counted as positive.
Number of participants with presence of anti-PF-04950615 antibodies were reported in this outcome measure.
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Day 1 up to Day 64
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2010年7月1日
一次修了 (実際)
2011年2月1日
研究の完了 (実際)
2011年4月1日
試験登録日
最初に提出
2010年7月14日
QC基準を満たした最初の提出物
2010年7月14日
最初の投稿 (見積もり)
2010年7月16日
学習記録の更新
投稿された最後の更新 (実際)
2018年3月1日
QC基準を満たした最後の更新が送信されました
2018年1月31日
最終確認日
2018年1月1日
詳しくは
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