The Phase I Clinical Study to Evaluate the Pharmacokinetics of Dw1029M in Healthy Male Volunteer
Randomized, Open-label, Single Dose, Crossover Phase I Clinical Study to Evaluate the Pharmacokinetics of DW1029M 300 mg, 600 mg and 1200 mg After Oral Administration in Healthy Male Volunteer
- Objective After single dose in healthy adults the capacity of the Group for DW1029M evaluate the pharmacokinetic characteristics.
- Indication Diabetic kidney disease
Efficacy
Primary
- AUClast, AUCinf, AUClast/D, AUCinf/D
- Cmax, Cmax/D
Secondary
- Tmax, t1/2, CL/F, Vz/F
Safety
- Adverse Event Monitoring
- V/S, EKG, Laboratory Test, P/E
調査の概要
詳細な説明
Healthy volunteers for clinical trials targeting drug administration date (1d) within 3 weeks from the (-21d ~-1d) in the interview, physical examination and laboratory tests , including through the screening is performed.
Through screening deems appropriate in this clinical trial is intended for the final subjects randomized to three groups to order .
The first phase one clinical trial subjects performed one day before (the -1 ) 18:00 Chonbuk National University Hospital, convened as a physical examination and perform hwalryeong signs .
One person to dinner , except for the drinking water should be fasting . One clinical trials (the first day) 20:00 subjects randomly assigned to groups according to the order in which the test is administered in a single oral medication .
The subjects for clinical trials with 240 mL water, medicines and swallow whole , chew before swallowing drugs should .
Blood according to the schedule after the clinical trial , including vital signs and physical examination is performed. The subjects that had a fixed schedule and is discharged on the morning of the second .
Is at least one week washout period . Since the two groups according to the order group and three creeping dose , except for the one the same tiles to proceed.
After a period of three clinical trials, three day period from taking drugs for clinical trials after 3-5 days to perform the post-study visit .
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
-
-
Geonjiro, Deokjin-gu
-
Jeonju-si, Jeollabuk-do、Geonjiro, Deokjin-gu、大韓民国、561-712
- Chonbuk National University Hospital
-
-
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:
- More than 20 years of age at the time of screening and less than 55 years old healthy male
(17.5 ~ 30.5 kg/m2 body mass index (BMI) and weight 45 kg or more
☞ body mass index (BMI) = weight (kg) / height (m) 2
- No congenital or chronic diseases, internal medicine examination results who does not have psychotic symptoms or findings
Exclusion Criteria:
- Clinically significant blood, kidney, endocrine, respiratory, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but, at the time of administration of seasonal allergic untreated asymptomatic except for sex), medical history or evidence
- Drugs that may affect the absorption of all the states (eg, gastrectomy)
- Investigational drugs within two months before the first dose participated in other clinical trials
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：基礎科学
- 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 |
|---|---|
|
実験的：A Group
|
DW1029M300mg PO Once
他の名前：
DW1029M300mg 2 tablets Once
他の名前：
DW1029M300mg 4 tablets PO Once
他の名前：
|
|
実験的：B Group
|
DW1029M300mg PO Once
他の名前：
DW1029M300mg 2 tablets Once
他の名前：
DW1029M300mg 4 tablets PO Once
他の名前：
|
|
実験的：C Group
|
DW1029M300mg PO Once
他の名前：
DW1029M300mg 2 tablets Once
他の名前：
DW1029M300mg 4 tablets PO Once
他の名前：
|
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 |
時間枠 |
|---|---|
|
Maximum Concentration of DW1029M in plasma
時間枠：24 hours
|
24 hours
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Area under concentration-time curve of DW1029M in plasma
時間枠：24hours
|
24hours
|
|
Time to maximal concentration of DW1029M in Plasma
時間枠：24hours
|
24hours
|
|
Elimination half time of DW1029M in Plasma
時間枠：24hours
|
24hours
|
|
Apparent clearance of DW1029M in Plasma
時間枠：24hours
|
24hours
|
|
Apparent volume of distribution of DW1029M in Plasma
時間枠：24hours
|
24hours
|
協力者と研究者
捜査官
- スタディディレクター：Cheol-hee Lim, CR Manager、DongWha Pharmaceutical Company
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。