Phase 1 Clinical Trial of DW340 and DW330SR + DW1030 Co-administration in Healthy Male Volunteers

NCT ID: NCT02380976

Last Updated: 2016-10-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31

Brief Summary

A randomized, open-label, single-dose, crossover Phase I Study to investigate the relative bioavailability of DW340 and DW330SR + DW1030 co-administration in healthy male volunteers.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Test 1

First phase: DW330SR+DW1030 7 days after Second phase: DW340

Group Type: EXPERIMENTAL

combination drug: DW330SR, DW1030

Intervention Type: DRUG

DW340

Intervention Type: DRUG

Test 2

First phase: DW340 7 days after Second phase: DW330SR+DW1030

Group Type: EXPERIMENTAL

combination drug: DW330SR, DW1030

Intervention Type: DRUG

DW340

Intervention Type: DRUG

Interventions

combination drug: DW330SR, DW1030

Intervention Type: DRUG

DW340

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age at screening visit only 20 healthy men over the age of 40 years or less
• Screening visit, BMI measurement is more than 19 kg/m2 who are below 27 kg/m2
• Screening vist, 90 mmHg ≤ SBP ≤ 140 mmHg, 50 mmHg ≤ DBP ≤ 90 mmHg
• Fully understand the purpose of trial, test drug and follow the instructions of the trial, Those who voluntarily written consent that ability and decision to participate during the entire period of the test

Exclusion Criteria

• Those with a clinically significant history or character; Liver, kidney, digestive, respiratory, musculoskeletal, endocrine, neuropsychiatric, blood • tumor type, cardiovascular disease
• Those with Gastrointestinal diseases that may affect the absorption of the IND or history of surgery
• Those who have a clinically significant history of hypersensitivity to drug and food
• Those with genetic problems, such as galactose intolerance, lactase deficiency or glucose-galactose malabsorption
• Within 60 days those taking the other clinical trial drug
• Within 30 days those who take the drug metabolizing enzyme induction and inhibition drugs or prescription drugs
• Within 30 days those who take food abnormally, that may affect ADME of drug
• Within 60 days those who donate whole blood, within 30 days those who donate blood partially, receive transfusion
• Within 14 days those who take OTC drug
• Those who showing positive for drug abuse concerns in urine drug testing
• Those who drink excessive alcohol or have history of alcoholism
• Heavy smoker
• and so on

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Daewon Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

DW340-1002

Identifier Type: -

Identifier Source: org_study_id