Ignite Creation Date:
2025-12-25 @ 4:24 AM
Ignite Modification Date:
2026-03-02 @ 8:03 PM
Study NCT ID:
NCT03316820
Status:
COMPLETED
Last Update Posted:
2019-05-03
First Post:
2017-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioavailability Study of K0706 in Healthy Subjects
Sponsor:
Sun Pharma Advanced Research Company Limited
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2019-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 capsule formulation under fasted conditions and to evaluate the food-effect for tablet formulation in healthy subjects.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: