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

Daewon Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02380976

DW340-1002

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: Male

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Test 1

Experimental group

Description:

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

Treatment:

Drug: DW340

Drug: combination drug: DW330SR, DW1030

Test 2

Experimental group

Description:

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

Treatment:

Drug: DW340

Drug: combination drug: DW330SR, DW1030