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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02380976

Enrollment

Registered

2015-03-05

Start date

2015-10-31

Completion date

Unknown

Last updated

2016-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

DRUGcombination drug: DW330SR, DW1030

DRUGDW340

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 40 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
AUClast of DW1030	9 days
Cmax of DW1030	9 days
AUClast of DW330SR	9 days
AUClast of DW340	9 days
Cmax of DW330SR	9 days
Cmax of DW340	9 days

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026