- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01309139
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
연구 개요
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
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-
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Ingelheim, 독일
- 1298.2.1 Boehringer Ingelheim Investigational Site
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Treatment A: Tiotropium medium dose
Oral inhalation daily for 21 days
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Medium dose of oral inhalation
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실험적: 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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실험적: Treatment B: Tiotropium medium dose
Oral inhalation daily for 21 days
|
Medium dose of oral inhalation
|
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실험적: Treatment C: BI 54903 high dose
Oral inhalation daily for 21 days
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Medium dose of oral inhalation
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Area under the concentration time curve of CD 1857 in plasma over a uniform dosing interval τ (AUCτ,ss)
기간: 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)
기간: 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
기간: 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
기간: on several time points until day 22
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on several time points until day 22
|
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
AUCτ,ss for BI 54903
기간: 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
기간: 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
기간: on Day 1 and 21
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on Day 1 and 21
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Change in physical examination
기간: 9 weeks
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9 weeks
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Change in vital signs
기간: 9 weeks
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9 weeks
|
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Change in 12-lead electrocardiogram
기간: 9 weeks
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9 weeks
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Change in clinical laboratory tests
기간: 9 weeks
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9 weeks
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Occurrence of Adverse Events
기간: 9 weeks
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9 weeks
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Assessment of tolerability by the investigator
기간: 9 weeks
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9 weeks
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 1298.2
- 2010-023780-18 (EudraCT 번호: EudraCT)
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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