Bioavailability Study of K0706 in Healthy Subjects
- Registration Number
- NCT03316820
- Lead Sponsor
- Sun Pharma Advanced Research Company Limited
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
- Willingness to provide written, informed consent for participation in the study in the compliance with the protocol requirements
- Adult males or females aged between 18 and 55 years
- Medically healthy on the basis of medical history and physical examination
- Woman of childbearing potential must practice an acceptable method of birth control
Exclusion Criteria
- History of any major surgical or medical conditions within 4 weeks prior to dosing
- History of blood transfusion and / or plasmapheresis within 4 weeks prior to dosing
- Inability to swallow oral medication and / or difficulty to find peripheral access to veins or inability to undergo venipuncture
- Any malignancy within the past 3 years (except for non-melanoma skin cancer or cervical cancer in situ)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Treatment D K0706 K0706 capsule Treatment B K0706 K0706 tablet Treatment A K0706 K0706 tablet Treatment C K0706 K0706 tablet
- Primary Outcome Measures
Name Time Method Observed peak plasma concentration 72 hours
- Secondary Outcome Measures
Name Time Method Adverse event 26 days
Trial Locations
- Locations (1)
SPARC Site 1
🇺🇸Las Vegas, Nevada, United States