- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01071720
The Effect of Food on the Pharmacokinetic Characteristics of CKD-501 (CKD-501 FDI)
Clinical Study to Assess the Effect of Food on the Pharmacokinetic Characteristics of CKD-501 in Healthy Subjects
The purpose of this study is to assess the effect of food on the pharmacokinetic characteristics of CKD-501 in healthy subject.
And, secondarily, pharmacokinetic characteristics of the main metabolites will be identified.
연구 개요
상세 설명
Healthy volunteers are administrated single-dose (CKD-501 1mg), two treatment(fed vs. fasting), two-period, two sequence crossover.
Every time before and after each medication, PK parameters and safety of CKD-501 1mg is performed using a blood sample and conducting some tests respectively.
연구 유형
등록 (예상)
단계
- 1단계
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Between 20 aged and 45 aged in healthy adults
- Weight more than 45kg, IBW 20% within the range
- Agreement with written informed consent
Exclusion Criteria:
- Subject has symptoms of acute disease within 28 days of starting administration of investigational drug
- Subject with known for history(such as inflammatory gastrointestinal disease, gastric or duodenal ulcer, liver diseases and so on) with affect the ADME of drug
- Clinically significant, active gastrointestinal system, cardiovascular system, pulmonary system, renal system, endocrine system, blood system, digestive system, central nervous system, mental disease or malignancy disease
- Inadequate subject by medical examination(medical history, physical examination, ECG, laboratory test) within 28 days of starting administration of investigational drug
Inadequate result of laboratory test
- AST(SGOT) or ALT(SGPT) > 1.25 x upper limit of normal range
- Total bilirubin > 1.5 x upper limit of normal range
- Clinically significant allergic disease(Except for mild allergic rhinitis seems to be not need for medication)
- Subject with known for hypersensitivity reactions to glitazone
- Previously participated in other trial within 60 days
- Treatment with dug-medicated induction/inhibition metabolic enzyme such as barbiturates within 1 month or with may affect the clinical trial within 10 days
- Subject takes an abnormal meal which affect the ADME of drug
- Not able to taking the institutional standard meal
- Previously make whole blood donation within 60 days or component blood donation within 20 days
- Continued to be taking caffeine (caffeine > 5 cup/day), drinking(alcohol > 30 g/day) or during clinical trials can not be drunk or severe heavy smoker (cigarette > 10 cigarettes per day)
- An impossible one who participates in clinical trial by investigator's decision including for reason of laboratory test result
- Subject who not practice contraception during clinical trial or pregnant women(including positive pregnancy test) or nursing mothers
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
다른: CKD-501 1mg (fed-fasted group)
CKD-501 1mg should be administered following a high-fat, high-caloric diet(fed condition) in one period and on an empty stomach(fasting condition) in the other period.
|
This study is randomized, balanced, single-dose, two treatment (fed versus fasting), two-period, two sequence crossover design to assess the effects of food on pharmacokinetics profile.
|
다른: CKD-501 1mg (fasted-fed group)
CKD-501 1mg should be administered on an empty stomach(fasting condition) in one period and following a high-fat, high-caloric diet(fed condition) in the other period.
|
This study is randomized, balanced, single-dose, two treatment (fed versus fasting), two-period, two sequence crossover design to assess the effects of food on pharmacokinetics profile.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
To evaluate the pharmacokinetics of CKD-501 1mg (fed vs. fasting)
기간: 0-48 hrs
|
0-48 hrs
|
2차 결과 측정
결과 측정 |
기간 |
---|---|
To evaluate the safety of CKD-501 1mg from vital signs, physical exam, ECG, laboratory test, adverse event and so on
기간: Throughout the trial
|
Throughout the trial
|
공동 작업자 및 조사자
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
키워드
기타 연구 ID 번호
- CKD-19HPS09L
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. .
CKD-501 1mg에 대한 임상 시험
-
Chong Kun Dang Pharmaceutical완전한
-
Chong Kun Dang Pharmaceutical완전한
-
Chong Kun Dang Pharmaceutical완전한
-
Chong Kun Dang Pharmaceutical완전한
-
Chong Kun Dang Pharmaceutical완전한