Study to Compare the Pharmacokinetics of Dipyridamole in Three Different Asasantin Extended Release (ER) Formulations in Healthy Male and Female Volunteers
2014年10月23日 更新者:Boehringer Ingelheim
A Double-blind, Randomised, 3-way Cross-over Study to Compare the Pharmacokinetics of Dipyridamole in Three Different Asasantin ER Extended Release (ER) 200 mg Dipyridamole/25 mg ASA Formulations in Healthy Male and Female Volunteers
Comparative pharmacokinetics of dipyridamole in two new formulations of Asasantin ER compared to the present commercial formulation
調査の概要
状態
完了
条件
研究の種類
介入
入学 (実際)
18
段階
- フェーズ 1
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
21年~50年 (大人)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
Inclusion Criteria:
- All participants in the study should be healthy males or females, range from 21 to 50 years of age and be within ± 20 % of their normal weight (Broca-Index)
- Prior to admission to the study all volunteers will have given, in accordance with good clinical practice (GCP) and the local legislation, their written informed consent
- Subsequently each subject will have his medical history taken and will receive a complete medical examination (incl. blood pressure and pulse rate measurements) as well as a 12-lead ECG
- Hematopoietic, hepatic and renal function tests will be carried out in the laboratory
- The subjects will fast for 12 hours before collection of specimens for all laboratory evaluations
- The above mentioned examinations will be performed within 14 days before the first administration of the test substance
Exclusion Criteria:
- Volunteers are excluded from the study if the results of the medical examination or laboratory tests are judged by the clinical investigator to differ significantly from normal clinical values
- Subjects with known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Subjects with diseases of the central nervous system (such as epilepsy) or with psychiatric or neurological disorders
- History of orthostatic hypotension, fainting spells or blackouts
- Subjects with chronic or relevant acute infections
- Subjects with allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- Volunteers who have taken a drug with a long half-life (≥ 24 hours) within one month or less than ten half-lives of the respective drug before enrolment in the study
- Volunteers who receive any other drugs which might influence the results of the trial during the week previous to enrolment in the study
- Volunteers who participate in another study with an investigational drug within the last two months preceding the study
- Volunteers who are unable to refrain from smoking on study days
- Volunteers who smoke more than10 cigarettes (or equivalent) per day
- Volunteers who drink more than 60 g of alcohol per day
- Volunteers who are dependent on drugs
- Volunteers who donate blood (≥ 100 mL) within the last four weeks
- Volunteers who participate in excessive physical activities within the last week before the study (e.g. competitive sports)
- Volunteers who suffer from any other disease or abnormality of clinical relevance
- History of hemorrhagic diatheses
- History of gastro-intestinal ulcer, perforation or bleeding
- History of bronchial asthma
- History of glucose-6-phosphate dehydrogenase (G-6-PD) deficiency
Female subjects:
- Pregnancy
- Positive pregnancy test
- No adequate contraception (adequate contraception e.g. sterilization, intrauterine devices (IUD), oral contraceptives)
- Inability to maintain this adequate contraception during the whole study period
- Lactation period
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
- 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:ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ:アササンチン ER、現在の市販製剤
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|
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実験的:Asasantin ER, new formulation I
|
|
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実験的:Asasantin ER, new formulation II
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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 |
|---|---|
|
Area under the concentration-time curve of dipyridamole in plasma at steady state (AUC,ss)
時間枠:Up to 48 hours after start of drug administration
|
Up to 48 hours after start of drug administration
|
|
Percent peak trough fluctuation of dipyridamole in plasma (%PTF)
時間枠:Up to 48 hours after start of drug administration
|
Up to 48 hours after start of drug administration
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Maximum concentration of the analytes in plasma at steady state (Cmax,ss)
時間枠:Up to 48 hours after start of drug administration
|
Up to 48 hours after start of drug administration
|
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Minimum measured concentration of the analytes in plasma at steady state over a uniform dosing interval τ (Cmin,ss)
時間枠:Up to 48 hours after start of drug administration
|
Up to 48 hours after start of drug administration
|
|
Time from dosing to the maximum measured concentration of the analytes in plasma at steady state over a uniform dosing interval τ Time from dosing to the maximum measured concentration of the analytes in plasma at steady state (tmax,ss)
時間枠:Up to 48 hours after start of drug administration
|
Up to 48 hours after start of drug administration
|
|
Percent area under the curve fluctuation of the analytes in plasma (AUCfluct)
時間枠:Up to 48 hours after start of drug administration
|
Up to 48 hours after start of drug administration
|
|
Terminal half-life of the analytes in plasma (t1/2)
時間枠:Up to 48 hours after start of drug administration
|
Up to 48 hours after start of drug administration
|
|
Percent of dose of the analytes recovered unchanged in urine (Ae%)
時間枠:Up to 24 hours after start of drug administration
|
Up to 24 hours after start of drug administration
|
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Ratio of peak concentration of the analytes in plasma over area under the curve at steady state (Cmax,ss / AUC,ss)
時間枠:Up to 48 hours after start of drug administration
|
Up to 48 hours after start of drug administration
|
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Number of subjects with clinically relevant changes in vital signs (blood pressure, pulse rate)
時間枠:up to 8 days after last study drug administration
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up to 8 days after last study drug administration
|
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Number of subjects with clinically relevant changes in 12-lead ECG
時間枠:up to 8 days after last study drug administration
|
up to 8 days after last study drug administration
|
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Number of subjects with clinically relevant changes in laboratory values
時間枠:up to 8 days after last study drug administration
|
up to 8 days after last study drug administration
|
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Number of subjects with adverse events
時間枠:up to 8 days after last study drug administration
|
up to 8 days after last study drug administration
|
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
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
便利なリンク
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
2001年4月1日
一次修了 (実際)
2001年5月1日
試験登録日
最初に提出
2014年10月23日
QC基準を満たした最初の提出物
2014年10月23日
最初の投稿 (見積もり)
2014年10月24日
学習記録の更新
投稿された最後の更新 (見積もり)
2014年10月24日
QC基準を満たした最後の更新が送信されました
2014年10月23日
最終確認日
2014年10月1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
- 9.144
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