Pharmacokinetic Drug Interaction Study in Healthy Male Subjects

• Status: Completed
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: LG Life Sciences
• Treatments: Ketoconazole; Rifampin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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