Unknown statusInterventionalPhase 1Updated Aug 15, 2022
Phase 1 Clinical Trial of DW340 and DW330SR + DW1030 Co-administration in Healthy Male Volunteers | NCT02380976 | Trialant
CompletedInterventionalPhase 1Updated Oct 12, 2016
Phase 1 Clinical Trial of DW340 and DW330SR + DW1030 Co-administration in Healthy Male Volunteers
ClinicalTrials.gov ID
NCT02380976
Lead Sponsor
Daewon Pharmaceutical Co., Ltd.INDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 1
Enrollment
24Actual
Last Update Posted
Oct 12, 2016Estimated
Start Date
Oct 2015
Primary Completion Date
Oct 2015Actual
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.
Healthy
combination drug: DW330SR, DW1030
DW340
Ages Eligible for Study
Adult (18-64)
Sexes Eligible for Study
Male
Accepts Healthy Volunteers
Yes
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
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