Bioavailability Study of K0706 in Healthy Subjects

Sun Pharma Advanced Research (SPARC)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: K0706

Study type: Interventional

Funder types: Industry

Identifiers

NCT03316820

CLR_17_07

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 4 patient groups

Treatment A

Experimental group

Description:

K0706 tablet

Treatment:

Drug: K0706

Drug: K0706

Treatment B

Experimental group

Description:

K0706 tablet

Treatment:

Drug: K0706

Drug: K0706

Treatment C

Experimental group

Description:

K0706 tablet

Treatment:

Drug: K0706

Drug: K0706

Treatment D

Experimental group

Description:

K0706 capsule

Treatment:

Drug: K0706

Drug: K0706