Bioavailability Study of K0706 in Healthy Subjects

Completed · Phase 1

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT03316820

Run by

Sun Pharma Advanced Research Company Limited

People needed

24

Starts

2017-10-28

Expected to finish

2017-11-21

Last updated by the study team

2019-05-03

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• SPARC Site 1 — Las Vegas, Nevada, United States

Full record on ClinicalTrials.gov

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