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

NCT02380976 | Completed Phase 1

• 1 other identifier: DW340-1002
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

Test 1

EXPERIMENTAL

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

Drug: combination drug: DW330SR, DW1030; Drug: DW340

Test 2

EXPERIMENTAL

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

Drug: combination drug: DW330SR, DW1030; Drug: DW340

Interventions

combination drug: DW330SR, DW1030 DRUG

Test 1; Test 2

DW340 DRUG

Test 1; Test 2

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Daewon Pharmaceutical Co., Ltd.: lead

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2015
• First Posted: March 5, 2015
• Study Start: October 1, 2015
• Primary Completion: October 1, 2015
• Last Updated: October 12, 2016

Record last verified: 2016-10