NCT03316820

Bioavailability Study of K0706 in Healthy Subjects

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Sun Pharma Advanced Research Company Limited · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	K0706	Study treatment with water after an overnight fast
DRUG	K0706	Study treatment with water after food

Timeline

• Start date: 2017-10-28
• Primary completion: 2017-11-21
• Completion: 2017-11-21
• First posted: 2017-10-20
• Last updated: 2019-05-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study