NCT Number: NCT02380976
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.
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Notify MeKey information
Conditions
Age range
20 year–40 year
Sex eligibility
Male
Study type
Interventional
Phase
Phase 1
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
DW340
DrugPrimary outcomes
-
Cmax of DW330SR
Time frame: 9 days
-
Cmax of DW340
Time frame: 9 days
-
Cmax of DW1030
Time frame: 9 days
-
AUClast of DW330SR
Time frame: 9 days
-
AUClast of DW340
Time frame: 9 days
-
AUClast of DW1030
Time frame: 9 days
Sponsors and collaborators
Lead sponsor
Daewon Pharmaceutical Co., Ltd.
Industry
Registry information
Important dates
- Study start
- 2015
- Primary completion
- 2015
- First posted
- Mar 5, 2015
- Registry last updated
- Oct 12, 2016
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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