A Study to Investigate Drug Interaction Between D326, D337, and D013 in Healthy Male Subjects
NCT ID: NCT03609606
Last Updated: 2018-10-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
69 participants
INTERVENTIONAL
2018-08-09
2018-09-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Part A, Sequence1
* Period 1: Treatment of D013, D326 and D337 on Day1\~Day7
* Period 2: Treatment of D013 on Day22\~Day28
D013, D326 and D337
Daily oral administration of 1 tablet for each drug under fasting conditions for 7 days
D013
Daily oral administration of 1 tablet under fasting conditions for 7 days
Part A, Sequence 2
* Period 1: Treatment of D013 on Day1\~Day7
* Period 2: Treatment of D013, D326 and D337 on Day22\~Day28
D013, D326 and D337
Daily oral administration of 1 tablet for each drug under fasting conditions for 7 days
D013
Daily oral administration of 1 tablet under fasting conditions for 7 days
Part B, Sequence 1
* Period 1: Treatment of D013, D326 and D337 on Day1\~Day7
* Period 2: Treatment of D326 and D337 on Day22\~Day28
D013, D326 and D337
Daily oral administration of 1 tablet for each drug under fasting conditions for 7 days
D326 and D337
Daily oral administration of 1 tablet for each drug under fasting conditions for 7 days
Part B, Sequence 2
* Period 1: Treatment of D326 and D337 on Day1\~Day7
* Period 2: Treatment of D013, D326 and D337 on Day22\~Day28
D013, D326 and D337
Daily oral administration of 1 tablet for each drug under fasting conditions for 7 days
D326 and D337
Daily oral administration of 1 tablet for each drug under fasting conditions for 7 days
Interventions
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D013, D326 and D337
Daily oral administration of 1 tablet for each drug under fasting conditions for 7 days
D013
Daily oral administration of 1 tablet under fasting conditions for 7 days
D326 and D337
Daily oral administration of 1 tablet for each drug under fasting conditions for 7 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Weight ≥ 50kg, with calculated body mass index(BMI) of ≥ 18 and ≤ 29.9kg/m²
3. Subjects who agree to use a combination of effective contraceptive methods or medically acceptable contraceptive methods for up to 28 days after the date of administration of the clinical trial drug and agree not to provide sperm
4. Subject who are informed of the investigational nature of this study, voluntarily agree to participate in this study
Exclusion Criteria
2. With symptoms indicating acute illness within 28 days prior to the first Investigational Product administration
3. Any medical history that may affect drug absorption, distribution, metabolism and excretion
4. Genetic problems such as galactose intolerance, Lapp lactose dehydrogenase deficiency or glucose-galactose uptake disorder
5. Any clinically significant active chronic disease
20 Years
45 Years
MALE
Yes
Sponsors
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Chong Kun Dang Pharmaceutical
INDUSTRY
Responsible Party
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Principal Investigators
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Ji-Young Park, M.D., Ph.D
Role: PRINCIPAL_INVESTIGATOR
Department of Pharmacology, College of Medicine/ Department of Clinical Pharmacology&Toxicology, Anam Hospital
Locations
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Korea University Anam Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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183DDI18011
Identifier Type: -
Identifier Source: org_study_id
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