- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02211950
Relative Bioavailability of BI 44847 in Different Ethnic Groups and Evaluation of Effect of Diet and Acarbose Coadministration on Bioavailability Following Oral Administration of 200 mg BI 44847 in Healthy Male Volunteers
2014년 8월 7일 업데이트: Boehringer Ingelheim
Evaluation of Relative Bioavailability of BI 44847 in Different Ethnic Groups (Subjects of White, Asian, and African Origin), and Evaluation of Effect of Diet and Acarbose Coadministration on Bioavailability Following Oral Administration of 200 mg BI 44847 in Healthy Male Volunteers. An Open-label, Single-dose, Parallel Group, Phase 1 Study (Group 1 With Additional Crossover Aspects)
The objectives were to investigate the relative bioavailability of BI 44847 in different racial groups (white, Asian, and African subjects) and to investigate the effect of different types of diet and acarbose coadministration on the bioavailability of BI 44847 in white subjects.
연구 개요
연구 유형
중재적
등록 (실제)
37
단계
- 1단계
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
남성
설명
Inclusion Criteria:
- Healthy male subjects determined by results of screening
- Age 18 - 40 years
- Body Mass Index 18 - 25 kg/m2, at least 45 kg
- Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation
Exclusion Criteria:
- Significant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders as judged by the investigator
- Relevant gastrointestinal tract surgery
- Diseases of the central nervous system (such as epilepsy, seizures) or psychiatric disorders or relevant neurological disorders
- History of relevant orthostatic hypotension, fainting spells or blackouts; systolic blood pressure greater than 140 mm Hg, diastolic blood pressure greater than 90 mm Hg, pulse rate out of 45 to 90 beats per minute
- Chronic or relevant acute infections
- History of allergy/hypersensitivity (including drug allergies) that are 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 within 10 days prior to administration or during the trial of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation
- Participation in another trial with an investigational drug within 2 months after a multiple dose study or within 1 month after a single dose study
- Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)
- Inability to refrain from smoking when confined to the study site on trial days
- Alcohol abuse (more than 60 g/day in males, more than 40 g/day in females)
- Drug abuse, in the investigator's judgment upon review of the patient's history and urine screening for abused substances
- Veins unsuited for iv 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)
- Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
- Excessive physical activities (within 48 hours prior to trial or during the trial)
- Any laboratory value outside the reference range that is of clinical relevance according to the assessment of the investigator
- Inability to comply with dietary regimen of study centre
- Subjects not able to understand and comply with protocol requirements, instructions and protocol-stated restrictions
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: Treatment A
single dose BI 44847 administered to white subjects
|
|
실험적: Treatment B
100 mg acarbose for 2 days, on the second day a single dose BI 44847 administered to white subjects
|
다른 이름들:
|
실험적: Treatment C
single dose BI 44847 after a Japanese diet of 6 days administered to white subjects
|
|
실험적: Treatment D
single dose BI 44847 administered to asian subjects
|
|
실험적: Treatment E
single dose BI 44847 administered to african subjects
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
Cmax (maximum concentration of the analyte in plasma)
기간: up to 48 hours after drug administration
|
up to 48 hours after drug administration
|
AUC0-∞ (area under the concentration time curve of the analyte in plasma in plasma over the time interval from 0 to infinity)
기간: up to 48 hours after drug administration
|
up to 48 hours after drug administration
|
AUC0-48 (area under the concentration time curve of the analyte in plasma over the time interval from 0 to 48 h)
기간: up to 48 hours after drug administration
|
up to 48 hours after drug administration
|
AUC0-12 (area under the concentration time curve of the analyte in plasma over the time interval from 0 to 12 h)
기간: up to 48 hours after drug administration
|
up to 48 hours after drug administration
|
2차 결과 측정
결과 측정 |
기간 |
---|---|
tmax (time from dosing to maximum concentration of the analyte in plasma)
기간: up to 48 hours after drug administration
|
up to 48 hours after drug administration
|
λz (terminal rate constant in plasma after single dose
기간: up to 48 hours after drug administration
|
up to 48 hours after drug administration
|
t1/2 (terminal half-life of the analyte in plasma after single dose)
기간: up to 48 hours after drug administration
|
up to 48 hours after drug administration
|
MRTpo (mean residence time of the analyte in the body after single dose)
기간: up to 48 hours after drug administration
|
up to 48 hours after drug administration
|
CL/F (apparent clearance of the analyte in the plasma after extravascular administration after single dose)
기간: up to 48 hours after drug administration
|
up to 48 hours after drug administration
|
Vz/F (apparent volume of distribution during the terminal phase λz after single dose following extravascular administration)
기간: up to 48 hours after drug administration
|
up to 48 hours after drug administration
|
AUCt1-t2 (area under the concentration time curve of analyte in plasma over the time interval t1 to t2)
기간: up to 24 hours after drug administration
|
up to 24 hours after drug administration
|
Aet1-t2 (amount of drug that is eliminated in urine from the time point t1 to time point t2)
기간: up to 24 hours after drug administration
|
up to 24 hours after drug administration
|
fet1-t2 (fraction of drug eliminated in urine from time point t1 to time point t2)
기간: up to 24 hours after drug administration
|
up to 24 hours after drug administration
|
CLR,t1-t2 (renal clearance of the drug from the time point t1 until the time point t2)
기간: up to 24 hours after drug administration
|
up to 24 hours after drug administration
|
Amount of glucose excreted in urine
기간: up to 24 hours after drug administration
|
up to 24 hours after drug administration
|
Number of patients with adverse events
기간: up to 48 hours after last administration of study drug
|
up to 48 hours after last administration of study drug
|
Number of patients with clinically relevant changes in laboratory tests
기간: up to 48 hours after last administration of study drug
|
up to 48 hours after last administration of study drug
|
Number of patients with clinically relevant changes in Electrocardiogram (ECG)
기간: up to 48 hours after last administration of study drug
|
up to 48 hours after last administration of study drug
|
Number of patients with clinically relevant changes in vital signs
기간: up to 48 hours after last administration of study drug
|
up to 48 hours after last administration of study drug
|
Assessment of global tolerability by investigator on a 4-point scale
기간: 48 hours after last administration of study drug
|
48 hours after last administration of study drug
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
유용한 링크
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2008년 10월 1일
기본 완료 (실제)
2008년 12월 1일
연구 등록 날짜
최초 제출
2014년 8월 7일
QC 기준을 충족하는 최초 제출
2014년 8월 7일
처음 게시됨 (추정)
2014년 8월 8일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2014년 8월 8일
QC 기준을 충족하는 마지막 업데이트 제출
2014년 8월 7일
마지막으로 확인됨
2014년 8월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 1224.22
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
BI 44847에 대한 임상 시험
-
Boehringer Ingelheim완전한
-
Boehringer Ingelheim완전한
-
Boehringer Ingelheim완전한
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Boehringer Ingelheim모병흑색종 | 비소세포폐암(NSCLC) | 머리와 목의 암종, 편평 세포(HNSCC)네덜란드
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Boehringer Ingelheim아직 모집하지 않음
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Boehringer Ingelheim완전한