Pharmacokinetics of the Fixed Dose Combination of Tiotropium Plus BI 54903 Versus the Combination of the Monoproducts of Tiotropium and BI 54903 in Healthy Volunteers
An Open Label, Randomised, Two-way Crossover Phase I Study to Assess Safety, Tolerability and Pharmacokinetics of the Fixed Dose Combination of Tiotropium Plus BI 54903 Via Respimat® B Versus the Combination of the Monoproducts of Tiotropium Via Respimat® A and BI 54903 Via Respimat® B in Healthy Volunteers
The primary objective is to compare the systemic exposure to tiotropium and CD 1857 after treatment with the fixed dose combination (fixed dose combination (FDC), Treatment A) of tiotropium plus BI 54903 (ethanolic solution for inhalation (EIS), Respimat (RMT) B) with the systemic exposure following inhalation of the free combination (Treatment B) of tiotropium (aqueous solution for inhalation (AIS), RMT A) plus BI 54903 (EIS, RMT B), when administered once-daily over 21 days via Respimat(R) (RMT).
The secondary objectives are:
to compare the systemic exposure to tiotropium and CD 1857 after single dose administration of FDC and of the free combination of tiotropium/BI 54903 to compare the systemic exposure to BI 54903 after a single dose and at steady state after multiple doses of the FDC and of the free combination of tiotropium/BI 54903 to compare the safety and tolerability of tiotropium and BI 54903 when administered as FDC and as free dose combination, respectively
調査の概要
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
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Ingelheim、ドイツ
- 1298.2.1 Boehringer Ingelheim Investigational Site
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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 males and females according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), clinical laboratory tests.
- Age 21 to 50 years.
Exclusion criteria:
- Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
- Any evidence of a clinically relevant concomitant disease
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- History or evidence of relevant psychiatric disorders or neurological disorders
- History or evidence of relevant autonomic dysfunction (orthostatic hypotension, fainting spells or blackouts)
- Chronic or relevant acute infections
- History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
- Intake of any prescription drugs or over-the-counter (over the counter (OTC)) medication (vitamins, herbal supplements, dietary supplements) 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
- Participation in another trial with an investigational drug within two months prior to administration or during the trial
- Smoker (more than 10 cigarettes daily)
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 |
|---|---|
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実験的:Treatment A: Tiotropium medium dose
Oral inhalation daily for 21 days
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Medium dose of oral inhalation
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実験的:Treatment A: BI 54903 high dose
Oral inhalation daily for 21 days
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Medium dose of oral inhalation
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|
実験的:Treatment B: Tiotropium medium dose
Oral inhalation daily for 21 days
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Medium dose of oral inhalation
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|
実験的:Treatment C: BI 54903 high dose
Oral inhalation daily for 21 days
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Medium dose of oral inhalation
|
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 CD 1857 in plasma over a uniform dosing interval τ (AUCτ,ss)
時間枠:on several time points until day 22
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on several time points until day 22
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Maximum concentration of CD 1857 in plasma at steady state (Cmax,ss)
時間枠:on several time points until day 22
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on several time points until day 22
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AUCτ,ss for Tiotropium
時間枠:on several time points until day 22
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on several time points until day 22
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Cmax,ss for Tiotropium
時間枠:on several time points until day 22
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on several time points until day 22
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
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AUCτ,ss for BI 54903
時間枠:on several time points until day 22
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on several time points until day 22
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Cmax,ss for BI 54903
時間枠:on several time points until day 22
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on several time points until day 22
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Ae0-24 (Amount of analyte that is eliminated in urine) for tiotropium
時間枠:on Day 1 and 21
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on Day 1 and 21
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Change in physical examination
時間枠:9 weeks
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9 weeks
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Change in vital signs
時間枠:9 weeks
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9 weeks
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Change in 12-lead electrocardiogram
時間枠:9 weeks
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9 weeks
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Change in clinical laboratory tests
時間枠:9 weeks
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9 weeks
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Occurrence of Adverse Events
時間枠:9 weeks
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9 weeks
|
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Assessment of tolerability by the investigator
時間枠:9 weeks
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9 weeks
|
協力者と研究者
スポンサー
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
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
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