Bioavailability Study of K0706 in Healthy Subjects
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 11/16/2018 |
| Start Date: | October 28, 2017 |
| End Date: | November 21, 2017 |
A Randomized, Open Label, Four Period, Four Sequence, Single Dose, Crossover Study to Evaluate 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
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.
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.
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)
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