Bioavailability Study of K0706 in Healthy Subjects

• Status: Completed
• Trial end date: 2017-11-21
• Target enrollment: 0
• Participant gender: All

Summary

This is single-center, single-dose, randomized, open-label, four-period, four sequence crossover study to evaluate the relative bioavailability of K0706 24 mg tablet formulation relative to 24 mg capsule formulation under fasted conditions and to evaluate the food-effect for tablet formulation in healthy subjects.

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

Details

• Lead Sponsor: Sun Pharma Advanced Research Company Limited

Criteria

Inclusion Criteria:

1. Willingness to provide written, informed consent for participation in the study in the compliance with the protocol requirements

2. Adult males or females aged between 18 and 55 years

3. Medically healthy on the basis of medical history and physical examination

4. Woman of childbearing potential must practice an acceptable method of birth control

Exclusion Criteria:

1. History of any major surgical or medical conditions within 4 weeks prior to dosing

2. History of blood transfusion and / or plasmapheresis within 4 weeks prior to dosing

3. Inability to swallow oral medication and / or difficulty to find peripheral access to veins or inability to undergo venipuncture

4. Any malignancy within the past 3 years (except for non-melanoma skin cancer or cervical cancer in situ)