Pharmacokinetics and Safety Study of Apetrol ES in Healthy Male Volunteers

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: Male

Summary

A Randomized, Open Label, Single dose, Cross-over, Phase I Trial to Investigate Safety and Pharmacokinetics of Apetrol ES and Megace® under Fed Conditions in Healthy Male Volunteers.

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

Details

• Lead Sponsor: LG Life Sciences
• Collaborator: Asan Medical Center
• Treatments: Megestrol Acetate

Criteria

Inclusion Criteria:

• Is a healty male between 20 and 55 years old

• Has BMI result between 19 and 26 kg/m2 at screening

• 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:

• Has had a serious illness or medical condition(s) regarding liver, kidney, gastrointestines, pulmonary systems, etc.

• Has had a medical history of gastrointestinal diseases which might affect drug absorption (i.e. Crohn's disease, ulcer) or surgical history.

• Is allergic against Megestrol acetate or other drugs (Aspirin, NSAIDs, Antibiotics, etc.) or against foods, or has an clinically serious allergic history