Bioequivalence Study of 2.5-mg Saxagliptin and 500-mg Glucophage in Tablets and a Fixed-dose Combination Tablet in Healthy Participants
2015年4月22日 更新者：AstraZeneca
Bioequivalence Study of the Fixed Dose Combination of 2.5 mg Saxagliptin and 500 mg Metformin Tablet Relative to a 2.5 mg Saxagliptin (Onglyza) Tablet and a 500 mg Metformin (Glucophage Marketed in Canada by Sanofi-Aventis) Tablet Co-Administered to Healthy Subjects in the Fasted and Fed States
To demonstrate the bioequivalence of a 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) tablet to that of 2.5-mg saxagliptin (Onglyza) and 500-mg metformin (Glucophage, marketed in Canada by Sanofi-Aventis) tablets coadministered to healthy participants in the fasted and fed states.
調査の概要
状態
完了
条件
研究の種類
介入
入学 (実際)
27
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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Texas
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Austin、Texas、アメリカ、78744
- PPD Development, LP
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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～55年 (大人)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Men and women, aged 18 to 55 years, inclusive
- Healthy participants as determined by a lack of clinically significant deviation from normal in medical history, physical examination, electrocardiograms, and clinical laboratory determinations
- Body Mass Index of 18 to 32 kg/m^2, inclusive
Exclusion Criteria:
- Any significant acute or chronic medical illness
- Current or recent (within 3 months) gastrointestinal disease
- Any major surgery within 4 weeks of study drug administration
- History of allergy to DPP-4 inhibitors or related compounds
- History of allergy or intolerance to metformin or other similar acting agents
- Previous exposure to saxagliptin
- Exposure to metformin within 3 months pervious to study drug administration
- Estimated creatinine clearance of <80 mL/min using the Cockcroft Gault formula
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
- 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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他の：Saxagliptin, 2.5 mg + Metformin, 500 mg (fasted state)
Single oral doses of saxagliptin, 2.5 mg, and metformin, 500 mg, administered together as tablets in the fasted state
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Tablets, oral, 2.5-mg saxagliptin and 500-mg metformin, once daily, 1 week
他の名前：
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他の：Saxagliptin, 2.5 mg/Metformin, 500 mg FDC (fasted state)
Single oral dose of a 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) tablet administered in the fasted state
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Tablets, oral, 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC), once daily, 1 week
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他の：Saxagliptin, 2.5 mg + Metformin, 500 mg (fed state)
Single oral doses of saxagliptin, 2.5 mg, and metformin, 500 mg, administered together as tablets in the fed state
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Tablets, oral, 2.5-mg saxagliptin and 500-mg metformin, once daily, 1 week
他の名前：
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他の：Saxagliptin, 2.5 mg/Metformin, 500 mg FDC (fed state)
Single oral dose of saxagliptin, 2.5 mg/metformin, 500 mg, FDC tablet administered in the fed state
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Tablets, oral, 2.5-mg saxagliptin and 500-mg metformin FDC, once daily, 1 week
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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 |
時間枠 |
|---|---|
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Observed Maximum Plasma Concentration (Cmax) of Saxagliptin, Tablets and Fixed-dose Combination (FDC), Administered to Participants in the Fasted and Fed States
時間枠：Days 1, 2, and 3 of Periods 1, 2, 3, and 4
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Days 1, 2, and 3 of Periods 1, 2, 3, and 4
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Observed Cmax of Metformin, Tablets and FDC, Administered to Participants in the Fasted and Fed States
時間枠：Days 1, 2, and 3 of Periods 1, 2, 3, and 4
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Days 1, 2, and 3 of Periods 1, 2, 3, and 4
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Terminal Half-life (t1/2) of Saxagliptin and Metformin, Tablets and FDC, Administered to Participants in the Fasted and Fed States
時間枠：Days 1, 2, and 3 of Periods 1, 2, 3, and 4
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Days 1, 2, and 3 of Periods 1, 2, 3, and 4
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Area Under the Plasma Concentration-time Curve From Time 0 to the Last Quantifiable Concentration (AUC[0-t]) for Saxagliptin, Tablets and FDC, Given in the Fasted and Fed States
時間枠：Days 1, 2, and 3 of Periods 1, 2, 3, and 4
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Days 1, 2, and 3 of Periods 1, 2, 3, and 4
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AUC[0-t] for Metformin, Tablets and FDC, Given in the Fasted and Fed States
時間枠：Days 1, 2, and 3 of Periods 1, 2, 3, and 4
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Days 1, 2, and 3 of Periods 1, 2, 3, and 4
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AUC From Time 0 Extrapolated to Infinity (AUC[0-inf]) for Saxagliptin, Tablets and FDC, Given in the Fasted and Fed States
時間枠：Days 1, 2, and 3 of Periods 1, 2, 3, and 4
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Days 1, 2, and 3 of Periods 1, 2, 3, and 4
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AUC[0-inf] for Metformin, Tablets and FDC, Administered in the Fasted and Fed States
時間枠：Days 1, 2, and 3 of Periods 1, 2, 3, and 4
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Days 1, 2, and 3 of Periods 1, 2, 3, and 4
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Time to Achieve the Observed Maximum Plasma Concentration (Tmax) for Saxagliptin and Metformin, Tablets and FDC, Administered to Participants in the Fasted and Fed States
時間枠：Days 1, 2, and 3 of Periods 1, 2, 3, and 4
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Days 1, 2, and 3 of Periods 1, 2, 3, and 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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Number of Participants With Death as Outcome, Serious Adverse Events, and Adverse Events (AEs) Leading to Discontinuation
時間枠：Continuously over Days 1 to 3 of treatment Periods 1, 2, 3, and 4
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An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment.
An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.
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Continuously over Days 1 to 3 of treatment Periods 1, 2, 3, and 4
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Number of Participants With Clinically Significant Abnormalities in Hematology, Serum Chemistry, and Urinalysis Laboratory Test Results
時間枠：At screening visit, at Day -1 of Periods 1 through 4, and at discharge
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Clinically significant was determined by the investigator.
Hematology tests included hemoglobin, hematocrit, red blood cell count, total leukocyte count (including differential), and platelet count.
Serum chemistry tests included aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, lactate dehydrogenase, creatinine, blood urea nitrogen, uric acid, fasting glucose, total protein, albumin, sodium, potassium, chloride, calcium, phosphorus, and creatine kinase.
Urinalysis included protein, glucose, blood, leukocyte esterase, specific gravity, and pH.
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At screening visit, at Day -1 of Periods 1 through 4, and at discharge
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Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Results
時間枠：At screening visit, Day -1 of Period 1, and at study discharge
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Clinically significant was determined by the investigator.
ECGs were recorded after participants had been supine for at least 5 minutes.
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At screening visit, Day -1 of Period 1, and at study discharge
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Number of Participants With Clinically Significant Abnormalities in Body Temperature, Blood Pressure, or Heart Rate
時間枠：At screening visit, prior to dosing on Day 1 of Periods 1 through 4, and at study discharge.
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Clinically significant was determined by the investigator.
Blood pressure and heart rate were measured after the participant had been seated quietly for at least 5 minutes.
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At screening visit, prior to dosing on Day 1 of Periods 1 through 4, and at study discharge.
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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
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
2010年3月1日
一次修了 (実際)
2010年3月1日
研究の完了 (実際)
2010年3月1日
試験登録日
最初に提出
2010年2月12日
QC基準を満たした最初の提出物
2010年2月12日
最初の投稿 (見積もり)
2010年2月15日
学習記録の更新
投稿された最後の更新 (見積もり)
2015年5月12日
QC基準を満たした最後の更新が送信されました
2015年4月22日
最終確認日
2015年4月1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。
2型糖尿病の臨床試験
Saxagliptin, 2.5 mg + Metformin, 500 mg (fasted state)の臨床試験
-
AstraZeneca完了
-
Boehringer IngelheimEli Lilly and Company完了