Healthy
Conditions
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.
Interventions
DRUGK0706
Study treatment with water after an overnight fast
Sponsors
Sun Pharma Advanced Research Company Limited
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Observed peak plasma concentration | 72 hours |
Secondary
| Measure | Time frame |
|---|---|
| Adverse event | 26 days |
Countries
United States
Outcome results
None listed