Pharmacokinetics of a Fixed Dose Combination of Canagliflozin/Metformin Coadministered With Food
A Single-Dose, Open-Label, Randomized, 2-Period Crossover Study to Assess the Effect of Food Coadministration on the Pharmacokinetics of a Fixed Dose Combination Tablet of Canagliflozin (JNJ-28431754) and Metformin Extended Release in Healthy Subjects
調査の概要
詳細な説明
This is a randomized (a sequence of fasted and fed periods accompanying study drug intake will be assigned by chance), open-label (physicians and participants know the identity of the assigned treatment), single-center, single-dose, 2-period, 2-sequence, crossover study of Canagliflozin/extended release Metformin (CANA/MET XR) fixed dose combination (FDC) tablet of 150 mg/1,000 mg. Approximately 24 healthy adult participants will be enrolled to ensure that at least 20 complete the study.
After a screening period, participants will be randomly assigned to 1 of the 2 treatment sequences (AB or BA) on Day 1 of Period 1. Treatment A means a participant will receive a single 150/1,000 mg CANA/MET XR FDC tablet under fasted conditions, and Treatment B means that a participant will receive the same drug under fed conditions. Participants will need to remain at the study center for 4 days (72 hours postdose) after the drug administration for collection of blood samples in each treatment period. There will be a 10- to 14-day washout period between Period 1 and Period 2. On Day 4 (72 hours postdose) of Period 2, when participants are discharged from the study center, they will be given instructions to return for a follow-up visit 7 to 10 days later. For Treatment B (in fed state), participants will be provided with a standardized high-fat breakfast. Participants' safety will be monitored throughout the study.
研究の種類
入学 (実際)
段階
- フェーズ 1
連絡先と場所
研究場所
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Nebraska
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Lincoln、Nebraska、アメリカ
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Must sign an informed consent document indicating they understand the purpose of the study and procedures
- Must have a body mass index (BMI) of between 18 and 30 kg/m², inclusive
- Must have a body weight of not less than 50 kg
- Must have a blood pressure between 90 and 140 mmHg inclusive, systolic, and no higher than 90 mmHg diastolic at screening
- Must have normal renal function and no evidence of kidney damage (including abnormalities in blood or urine tests)
Exclusion Criteria:
- History of or current clinically significant medical illness
- Use of any prescription or nonprescription medication (including vitamins and herbal supplements)
- History of clinically significant allergies, especially known hypersensitivity or intolerance to lactose- Known allergy to heparin or history of heparin induced thrombocytopenia
- History of smoking or use of nicotine-containing substances within the previous 2 months
研究計画
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：ランダム化
- 介入モデル：クロスオーバー割り当て
- 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：Sequence AB
A single dose of CANA/MET XR FDC tablet of 150 mg/1,000 mg under fasted conditions (treatment A) followed by the same single dose under fed conditions (treatment B).
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Canagliflozin/extended release Metformin (CANA/MET XR) fixed dose combination (FDC) tablet of 150 mg/1,000 mg
|
|
実験的：Sequence BA
A single dose of CANA/MET XR FDC tablet of 150 mg/1,000 mg under fed conditions (treatment B) followed by the same single dose under fasted conditions (treatment A).
|
Canagliflozin/extended release Metformin (CANA/MET XR) fixed dose combination (FDC) tablet of 150 mg/1,000 mg
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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 |
|---|---|---|
|
Plasma concentration of canagliflozin following the single dose of CANA/MET XR FDC after fed and fasted conditions
時間枠：Predose, (before tablet intake) up to 72 hours afterdose
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Plasma concentrations of canagliflozin are used to evaluate how long canagliflozin stays in the body.
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Predose, (before tablet intake) up to 72 hours afterdose
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Plasma concentration of metformin following the single dose of CANA/MET XR FDC after fed and fasted conditions
時間枠：Predose, up to 72 hours afterdose
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Plasma concentrations of metformin are used to evaluate how long metformin stays in the body.
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Predose, up to 72 hours afterdose
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Percentage of participants with adverse events as a measure of safety and tolerability
時間枠：Screening, up to Day 10 of the follow-up period
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Screening, up to Day 10 of the follow-up period
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協力者と研究者
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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