Overview
A Study to Investigate Drug Interaction Between D326, D337, and D013 in Healthy Male Subjects
Status:
Completed
Completed
Trial end date:
2018-09-27
2018-09-27
Target enrollment:
0
0
Participant gender:
Male
Male
Summary
A study to investigate drug interaction between D326, D337, and D013 in healthy male subjectsPhase:
Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Chong Kun Dang Pharmaceutical
Criteria
Inclusion Criteria:1. Healthy volunteers aged between ≥ 20 and ≤ 45 years old
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:
1. History or presence of clinically significant and active cardiovascular, respiratory,
hepatobiliary, renal, hematological, gastrointestinal, endocrine, immune,
dermatologic, neurologic or psychiatric disorder
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