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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: combination drug: DW330SR, DW1030; Drug: DW340

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test 1; First phase: DW330SR+DW1030 7 days after Second phase: DW340	Drug: combination drug: DW330SR, DW1030; Drug: DW340
Experimental: Test 2; First phase: DW340 7 days after Second phase: DW330SR+DW1030	Drug: combination drug: DW330SR, DW1030; Drug: DW340

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cmax of DW330SR	9 days
Cmax of DW340	9 days
Cmax of DW1030	9 days
AUClast of DW330SR	9 days
AUClast of DW340	9 days
AUClast of DW1030	9 days

Collaborators and Investigators

• Sponsor: Daewon Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: February 24, 2015
• First Submitted That Met QC Criteria: March 1, 2015
• First Posted (Estimate): March 5, 2015

Study Record Updates

• Last Update Posted (Estimate): October 12, 2016
• Last Update Submitted That Met QC Criteria: October 11, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: DW340-1002