Relative Bioavailability of Telmisartan and Dipyridamole After Co-administration Compared to the Bioavailability of Telmisartan or Dipyridamole Alone in Healthy Female and Male Subjects
Relative Bioavailability of Telmisartan in Micardis® and of Dipyridamole in Aggrenox® After Co-administration Compared to the Bioavailability of Telmisartan Respectively of Dipyridamole After Oral Administration of 80 mg Telmisartan Respectively of 25 mg ASA/200 mg Extended-release Dipyridamole Alone. An Open-label, Randomised, Single-dose, Four-way Crossover Study in 24 Healthy Female and Male Subjects
To investigate the relative bioavailability of telmisartan respectively of dipyridamole after concomitant administration of 80 mg telmisartan in Micardis® and 25 mg acetylsalicylic acid (ASA)/200 mg extended release (ER) dipyridamole (DP) in Aggrenox® (Test 1) relative to ER-DP in Aggrenox® alone (Reference 1), respectively relative to telmisartan in Micardis® alone (Reference 2).
To investigate the relative bioavailability of dipyridamole respectively of telmisartan administered as 25 mg ASA/200 mg ER-DP 30 minutes after intake of 80 mg telmisartan (Test 2) relative to dipyridamole in Aggrenox® alone (Reference 1), respectively relative to telmisartan in Micardis® alone (Reference 2).
調査の概要
研究の種類
入学 (実際)
段階
- フェーズ 1
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:
Healthy females and males according to the following criteria:
Based upon a complete medical history, including the physical examination, vital signs (BP, HR), 12-lead ECG, clinical laboratory tests
- No finding deviating from normal and of clinical relevance
- No evidence of a clinically relevant concomitant disease
- Age ≥21 and Age ≤65 years
- BMI ≥18.5 and BMI ≤29.9 kg/m2 (Body Mass Index)
- Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation
Exclusion Criteria:
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Surgery of gastrointestinal tract (except appendectomy)
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of relevant orthostatic hypotension, fainting spells or blackouts.
- Chronic or relevant acute infections
- History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- Intake of drugs with a long half-life (>24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
- Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
- Participation in another trial with an investigational drug within two months prior to administration or during the trial
- Smoker (more than 10 cigarettes/day or 3 cigars/day or 3 pipes/day)
- Inability to refrain from smoking on trial days
- Alcohol abuse (more than 60 g/day)
- Drug abuse
- Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
- Excessive physical activities (within one week prior to administration or during the trial)
- Any laboratory value outside the reference range that is of clinical relevance
- Inability to comply with dietary regimen of study centre
- History of hereditary fructose intolerance
- History of any familial bleeding disorder
- Veins unsuited for i.v. puncture on either arm (e.g. veins which are difficult to locate, access or puncture, veins with a tendency to rupture during or after puncture, etc.)
Inability to comply with the investigators instructions
For female subjects:
- Pregnancy
- Positive pregnancy test
- No adequate contraception e.g. oral contraceptives, sterilization, intrauterine device (IUD)
- Inability to maintain this adequate contraception during the whole study period
- Lactation period
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 |
---|---|
実験的:telmisartan and ASA/ER-DP (concomitant)
|
|
アクティブコンパレータ:ASA/ER-DP alone
|
|
実験的:telmisartan and ASA/ER-DP (consecutively)
|
|
アクティブコンパレータ:telmisartan
|
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 |
---|---|
AUC0-∞ (area under the concentration time curve in plasma from 0 extrapolated to infinity)
時間枠:up to 72 hours following drug administration
|
up to 72 hours following drug administration
|
Cmax (maximum concentration in plasma)
時間枠:up to 72 hours following drug administration
|
up to 72 hours following drug administration
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
有害事象発現例数
時間枠:最後の投薬から8日以内
|
最後の投薬から8日以内
|
|
臨床検査で臨床的に重要な結果が得られた被験者の数
時間枠:最後の投薬から8日以内
|
最後の投薬から8日以内
|
|
AUC0-tz (area under the concentration-time curve in plasma over the time interval from 0 to the time of the last quantifiable data point)
時間枠:up to 72 hours following drug administration
|
up to 72 hours following drug administration
|
|
AUCt1-t2 (Area under the concentration time curve in plasma over the time interval t1 to t2)
時間枠:up to 72 hours following drug administration
|
up to 72 hours following drug administration
|
|
tmax (time from dosing to the maximum concentration of the analytes in plasma)
時間枠:up to 72 hours following drug administration
|
up to 72 hours following drug administration
|
|
λz (terminal rate constant in plasma)
時間枠:up to 72 hours following drug administration
|
up to 72 hours following drug administration
|
|
t1/2 (terminal half-life of the analytes in plasma)
時間枠:up to 72 hours following drug administration
|
up to 72 hours following drug administration
|
|
MRTpo (mean residence time of the analyte in the body after p.o. administration)
時間枠:up to 72 hours following drug administration
|
up to 72 hours following drug administration
|
|
CL/F (apparent clearance of the analytes in the plasma after extravascular administration)
時間枠:up to 72 hours following drug administration
|
up to 72 hours following drug administration
|
|
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
時間枠:up to 72 hours following drug administration
|
up to 72 hours following drug administration
|
|
Number of subjects with clinically significant findings in vital signs
時間枠:up to 8 days after last drug administration
|
blood pressure, heart rate
|
up to 8 days after last drug administration
|
Number of subjects with clinically significant findings in 12 lead ECG
時間枠:up to 8 days after last drug administration
|
up to 8 days after last drug administration
|
|
Assessment of tolerability by the investigator on a 4-point scale
時間枠:up to 8 days after last drug administration
|
up to 8 days after last drug administration
|
協力者と研究者
スポンサー
出版物と役立つリンク
便利なリンク
研究記録日
主要日程の研究
研究開始
一次修了 (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
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 502.458
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