The Phase I Clinical Study to Evaluate the Pharmacokinetics of Dw1029M in Healthy Male Volunteer
Randomized, Open-label, Single Dose, Crossover Phase I Clinical Study to Evaluate the Pharmacokinetics of DW1029M 300 mg, 600 mg and 1200 mg After Oral Administration in Healthy Male Volunteer
- Objective After single dose in healthy adults the capacity of the Group for DW1029M evaluate the pharmacokinetic characteristics.
- Indication Diabetic kidney disease
Efficacy
Primary
- AUClast, AUCinf, AUClast/D, AUCinf/D
- Cmax, Cmax/D
Secondary
- Tmax, t1/2, CL/F, Vz/F
Safety
- Adverse Event Monitoring
- V/S, EKG, Laboratory Test, P/E
연구 개요
상세 설명
Healthy volunteers for clinical trials targeting drug administration date (1d) within 3 weeks from the (-21d ~-1d) in the interview, physical examination and laboratory tests , including through the screening is performed.
Through screening deems appropriate in this clinical trial is intended for the final subjects randomized to three groups to order .
The first phase one clinical trial subjects performed one day before (the -1 ) 18:00 Chonbuk National University Hospital, convened as a physical examination and perform hwalryeong signs .
One person to dinner , except for the drinking water should be fasting . One clinical trials (the first day) 20:00 subjects randomly assigned to groups according to the order in which the test is administered in a single oral medication .
The subjects for clinical trials with 240 mL water, medicines and swallow whole , chew before swallowing drugs should .
Blood according to the schedule after the clinical trial , including vital signs and physical examination is performed. The subjects that had a fixed schedule and is discharged on the morning of the second .
Is at least one week washout period . Since the two groups according to the order group and three creeping dose , except for the one the same tiles to proceed.
After a period of three clinical trials, three day period from taking drugs for clinical trials after 3-5 days to perform the post-study visit .
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
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Geonjiro, Deokjin-gu
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Jeonju-si, Jeollabuk-do, Geonjiro, Deokjin-gu, 대한민국, 561-712
- Chonbuk National University Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- More than 20 years of age at the time of screening and less than 55 years old healthy male
(17.5 ~ 30.5 kg/m2 body mass index (BMI) and weight 45 kg or more
☞ body mass index (BMI) = weight (kg) / height (m) 2
- No congenital or chronic diseases, internal medicine examination results who does not have psychotic symptoms or findings
Exclusion Criteria:
- Clinically significant blood, kidney, endocrine, respiratory, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but, at the time of administration of seasonal allergic untreated asymptomatic except for sex), medical history or evidence
- Drugs that may affect the absorption of all the states (eg, gastrectomy)
- Investigational drugs within two months before the first dose participated in other clinical trials
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: A Group
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DW1029M300mg PO Once
다른 이름들:
DW1029M300mg 2 tablets Once
다른 이름들:
DW1029M300mg 4 tablets PO Once
다른 이름들:
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실험적: B Group
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DW1029M300mg PO Once
다른 이름들:
DW1029M300mg 2 tablets Once
다른 이름들:
DW1029M300mg 4 tablets PO Once
다른 이름들:
|
|
실험적: C Group
|
DW1029M300mg PO Once
다른 이름들:
DW1029M300mg 2 tablets Once
다른 이름들:
DW1029M300mg 4 tablets PO Once
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Maximum Concentration of DW1029M in plasma
기간: 24 hours
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24 hours
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Area under concentration-time curve of DW1029M in plasma
기간: 24hours
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24hours
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Time to maximal concentration of DW1029M in Plasma
기간: 24hours
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24hours
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Elimination half time of DW1029M in Plasma
기간: 24hours
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24hours
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Apparent clearance of DW1029M in Plasma
기간: 24hours
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24hours
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Apparent volume of distribution of DW1029M in Plasma
기간: 24hours
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24hours
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공동 작업자 및 조사자
수사관
- 연구 책임자: Cheol-hee Lim, CR Manager, DongWha Pharmaceutical Company
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
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