- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00780013
Bioequivalence Study of Metformin Hydrochloride Liquid 500mg/ 5 mL Under Fed Conditions
Crossover Bioavailability Study on Metformin Formulations Comparing Metformin Hydrochloride Liquid 500 mg/5mL of Ranbaxy Laboratories With GlucophageA® 1000 mg Tablets of Bristol-Myers Squibb in Healthy, Adult, Male and Female Volunteers Under Fed Conditions, Following a 1000 mg Dose
연구 개요
상세 설명
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Quebec
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Saint-Laurent, Quebec, 캐나다
- MDS Pharma Services
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Be in the age range of 18-45 years.
- Weigh at least 60 kg for males and 52 kg for females and be within 15% of their ideal weights (Table of "Desirable Weights of Adults", Metropolitan Life Insurance Company, 1953).
- Have voluntarily given written informed consent to participate in this study.
- Be medically healthy with clinically normal laboratory profiles as determined by medical history, physical examination and laboratory tests performed within 28 days prior to the commencement of the study.
Females of childbearing potential should either be sexually inactive (abstinent) for 14 days prior to the study and throughout the study or be using one of the following acceptable birth control methods:
- Surgically sterile (tubal ligation, hysterectomy, bilateral oophorectomy) 6 months minimum. Proof is required for the hysterectomy and oophorectomy;
- IUD in place for at least 3 months
- Barrier methods with spermicide (condom, diaphragm) for at least 14 days prior to the start of the study and throughout the study
- Surgical sterilization of the partner (vasectomy for 6 months minimum)
- Hormonal contraceptives for at least 3 months prior to the start of the study. Other birth control methods may be deemed acceptable. Post-menopausal women with amenorrhea for at least 2 years will be eligible.All female subjects will be asked to confirm compliance with an approved and effective method of birth control and to sign a declaration form to this effect.
Exclusion Criteria:
- History of allergy to metformin and other related antidiabetic biguanide preparations.
- Any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations
- History of serious gastrointestinal, hepatic, renal, cardiovascular, pulmonary, endrocrine, immunologic, dermatologic, neurological or haematological
- disease, diabetes or glaucoma.
- History of any psychiatric illness which may impair the ability to provide written informed consent.
- Regular smokers who smoke more than 10 cigarettes daily or have difficulty abstaining from smoking from 1 hour before dosing and up to 6 hour following drug administration in each study period.
- Subjects who have had problems with drug or alcohol abuse within the past year or will have difficulty in abstaining for the duration of each study period.
- Participation in any clinical trial within 28 days of study start
- Subjects who have been on an abnormal diet (for whatever reason) during the 28 days preceding the first dosing.
- Females who are pregnant or lactating.
- Subjects without adequate venous access in their left or right arm to allow collection of 38 blood samples via venipuncture in the 2 periods.
- Subjects who, through completion of the study, would have donated in excess of:
500 mL of blood in 14 days 500 - 750 mL of blood in 14 days (unless approved by the Principal Investigator) 1000 mL of blood in 90 days 1250 mL of blood in 120 days 1500 mL of blood in 180 days 2000 mL of blood in 270 days 2500 mL of blood in 1 year 13) Presence of values that are significantly different from normal reference ranges, as judged by the physician
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 1
metformin hydrochloride (HCI) liquid 500 mg/5 mL of Ranbaxy
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활성 비교기: 2
Glucophage® 1000 mg tablets
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
---|
생물학적 동등성
|
공동 작업자 및 조사자
간행물 및 유용한 링크
유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
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
- 05/METFO-500/01
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. .
metformin hydrochloride liquid 500 mg per 5 mL에 대한 임상 시험
-
Christian Medical College and Hospital, Ludhiana...All India Institute of Medical Sciences, New Delhi; Indian Council of Medical Research; King... 그리고 다른 협력자들모병
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