治験レーダーAI | ||
|---|---|---|
治験 NCT01874080（対象：糖尿病）は完了です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
フィルター基準に一致する試験が1件見つかりました
タイル表示
検索に戻る
アストラゼネカBioequivalence Study 第I相・フェーズ1 56
治験（臨床試験）の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします！「治験解説」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT01874080 は 介入研究 臨床試験 で、糖尿病 を対象とした研究でした。現在は 完了 です。2013年6月1日 に開始し、56 名の参加者 が参加しました。この試験は アストラゼネカ によって主導され、2013年7月1日 に完了しました。ClinicalTrials.gov からの最新更新日は 2015年4月23日 です。
概要
The purpose of this study is to determine if tablets manufactured at different sites have the same bioavailability, that is yield similar blood levels/concentrations of the drugs and are handled by the body similarly
詳細説明
Primary Purpose:
Other: Protocol designed to demonstrate the bioequivalence of the fixed dose combination of 5 mg Saxagliptin and 1000 mg Metformin Extended Release Tablet manufactured in Mt. Vernon, Indiana and Humacao, Puerto Rico relative to the fixed dose combination tablet manufactured in Mt. Vernon, Indiana and the bioequivalence of the fixed dose combination of 5 mg Saxagliptin and 500 mg Metformin Extended R...
もっと見る公式タイトル
Bioequivalence Study of the Fixed Dosed Combination of 5 mg Saxagliptin and 1000 mg Metformin Extended Release Tablet Manufactured in Mt. Vernon, Indiana and Humacao, Puerto Rico Relative to the Fixed Dosed Combination Tablet Manufactured in Mt. Vernon, Indiana and Bioequivalence Study of the Fixed Dosed Combination of 5 mg Saxagliptin and 500 mg Metformin Extended Release Tablet Manufactured in Mt. Vernon, Indiana and Humacao, Puerto Rico Relative to the Fixed Dosed Combination Tablet Manufactured in Mt. Vernon, Indiana Administered to Healthy Subjects Under Fed Conditions
疾患名
糖尿病その他の研究識別子
- CV181-208
割付方法
無作為化
介入モデル
クロスオーバー法
盲検化
なし（非盲検）
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的Arm A: Saxagliptin/Metformin XR FDC (Mt. Vernon/Humacao) Saxagliptin 5 mg /Metformin 1000 mg (Mt. Vernon/Humacao) tablet by mouth once daily on Day 1 of Periods 1 and 2 | Saxagliptin/Metformin |
実験的Arm B: Saxagliptin/Metformin XR FDC (Mt. Vernon) Saxagliptin 5 mg/Metformin 1000 mg (Mt. Vernon) tablet by mouth once daily on Day 1 of Periods 1 and 2 | Saxagliptin/Metformin |
実験的Arm C: Saxagliptin/Metformin XR FDC (Mt. Vernon/Humacao) Saxagliptin 5 mg/Metformin 500 mg (Mt. Vernon/Humacao) tablet by mouth once daily on Day1 of Periods 1 and 2 | Saxagliptin/Metformin |
実験的Arm D: Saxagliptin/Metformin XR FDC (Mt. Vernon) Saxagliptin 5 mg/Metformin 500 mg (Mt. Vernon) tablet by mouth once daily Day 1 of Periods 1 and 2 | Saxagliptin/Metformin |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Point estimates and 90% CIs for the ratio of geometric means for Cmax for Saxagliptin and Metformin in the 5/1000 mg FDC XR (Mt.Vernon/Humacao) and 5/1000 mg FDC XR (Mt. Vernon) | Cmax=Maximum observed plasma concentration
CI=Confidence interval
FDC=Fixed dosed combination
XR=Extended release | 19 time points up to Day 3 of Periods 1 and 2 |
Point estimates and 90% CIs for the ratio of geometric means for AUC(0-T) for Saxagliptin and Metformin in the 5/1000 mg FDC XR (Mt.Vernon/Humacao) and 5/1000 mg FDC XR (Mt. Vernon) | AUC(0-T)=Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration | 19 time points up to Day 3 of Periods 1 and 2 |
Point estimates and 90% CIs for the ratio of geometric means for AUC(INF) for Saxagliptin and Metformin in the 5/1000 mg FDC XR (Mt.Vernon/Humacao) and 5/1000 mg FDC XR (Mt. Vernon) | AUC(INF)=Area under the plasma concentration-time curve from time zero extrapolated to infinity | 19 time points up to Day 3 of Periods 1 and 2 |
Point estimates and 90% CIs for the ratio of geometric means for Cmax for Saxagliptin and Metformin in the 5/500 mg FDC XR (Mt. Vernon/Humacao) and 5/500 mg FDC XR (Mt. Vernon) | 19 time points up to Day 3 of Periods 1 and 2 | |
Point estimates and 90% CIs for the ratio of geometric means for AUC(0-T) for Saxagliptin and Metformin in the 5/500 mg FDC XR (Mt. Vernon/Humacao) and 5/500 mg FDC XR (Mt. Vernon) | 19 time points up to Day 3 of Periods 1 and 2 | |
Point estimates and 90% CIs for the ratio of geometric means for AUC(INF) for Saxagliptin and Metformin in the 5/500 mg FDC XR (Mt. Vernon/Humacao) and 5/500 mg FDC XR (Mt. Vernon) | 19 time points up to Day 3 of Periods 1 and 2 |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Time to maximum observed plasma concentration (Tmax) for Saxagliptin and Metformin and for 5-OH Saxagliptin (Treatments A, B, C, and D) | 19 time points up to Day 3 of Periods 1 and 2 | |
Terminal half life (T-HALF) for Saxagliptin and Metformin and for 5-OH Saxagliptin (Treatments A, B, C, and D) | 19 time points up to Day 3 of Periods 1 and 2 | |
Cmax for 5-OH Saxagliptin (Treatments A, B, C, and D) | 19 time points up to Day 3 of Periods 1 and 2 | |
AUC(0-T) for 5-OH Saxagliptin (Treatments A, B, C, and D) | 19 time points up to Day 3 of Periods 1 and 2 | |
AUC(INF) for 5-OH Saxagliptin (Treatments A, B, C, and D) | 19 time points up to Day 3 of Periods 1 and 2 | |
Safety assessments based on adverse event reports and the results of vital sign measurements, ECGs, physical examinations, and clinical laboratory tests | Parameters will include:
1. Serious adverse events
2. Deaths
3. Adverse events leading to discontinuation
4. Number of subjects with potentially clinically significant changes in vital signs, electrocardiograms (ECGs) or safety laboratory findings defined as meeting marked abnormality criteria | Up to Day 3 of Periods 1 and 2 and up to 30 days post discontinuation of dosing |
適格基準
対象年齢
成人
試験の最低年齢
18 Years
対象性別
全て
健康なボランティアを受け入れる
はい
- Healthy male and female subjects, 18-45 years of age
- Body mass index (BMI) of 18.0 to 30.0 kg/m2, inclusive
- Women must have a negative serum or urine pregnancy test within 24 hours prior to the start of investigational product
- Any significant acute or chronic medical illness
- Estimated creatinine clearance of <60 mL/min as calculated using the Modification of Diet in Renal Disease method Current or recent (within 3 months of study drug administration)
- Gastrointestinal (GI) disease that could affect the absorption of study drug
- Inability to tolerate oral medication
- History of allergies or adverse reactions to DPP4 inhibitors or Metformin or related compounds
- Current smoker or recent (within 6 months of study drug administration) history of regular tobacco use (positive cotinine test)
アストラゼネカ772 件のアクティブな治験を探索連絡先情報がありません。
1 1カ国の場所
Texas
Icon Development Solutions, San Antonio, Texas, 78209, United States