Status:
COMPLETED
Pharmacokinetic Drug Interaction Study in Healthy Male Subjects
Lead Sponsor:
LG Life Sciences
Conditions:
Healthy Male Volunteers
Eligibility:
MALE
20-50 years
Phase:
PHASE1
Brief Summary
A Randomized, Open Label, Drug-Drug interaction study to investigate effect of ketoconazole or rifampicin on the Pharmacokinetic characteristics and safety of LC15-0444 in Healthy Male Volunteers.
Detailed Description
This study is a randomized, open-label, 2-period, 3-treatment, 1-sequence, drug-drug interaction study in healthy volunteers to evaluate effect of ketoconazole or rifampicin on the PK characteristic a...
Eligibility Criteria
Inclusion
- Is a healthy male between 20 and 50 years old
- Has BMI result between 19 and 26 kg/m2 at screening; and a total body weight over 55 kg. BMI(kg/m2) = body weight(kg)/{height(m)}2.
- Is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
- Agrees to use an adequate means of contraception during clinical trials
Exclusion
- Subjects with evidence or history of clinically significant hepatic, renal, digestive, neurologic, pulmonary, musculoskeletal, endocrine, hematological, cardiovascular or psychiatric disease
- Subjects with evidence or history of gastrointestinal disease or surgery possibly affecting drug absorption.
- Subjects with history of hypersensitivities or clinically significant adverse events caused by DPPIV inhibitors, ketoconazole, rifampicin, and other drugs
- Subjects who have donated a unit of blood within 60 days or blood components within 30 days before the first administration of the investigational product.
- Subjects who consume excessive alcohol or caffeine; who excessively smoke
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01426906
Start Date
January 1 2011
End Date
March 1 2011
Last Update
September 1 2011
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea