Status:
COMPLETED
Bioavailability Study of K0706 in Healthy Subjects
Lead Sponsor:
Sun Pharma Advanced Research Company Limited
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 caps...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 28 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 21 2017
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03316820
Start Date
October 28 2017
End Date
November 21 2017
Last Update
May 3 2019
Active Locations (1)
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1
SPARC Site 1
Las Vegas, Nevada, United States, 89121