Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06360445
Status:
COMPLETED
Last Update Posted:
2024-04-11
First Post:
2024-04-07
Brief Title:
Bioequivalence Study of Olaparib Tablets Under Fasting and Fed Conditions in Healthy Subjects
Sponsor:
CSPC Ouyi Pharmaceutical Co Ltd
Organization:
CSPC Ouyi Pharmaceutical Co Ltd
Study Overview
Official Title:
A Randomized Open-Label 2-formulation Single-Dose 2-Period Crossover Bioequivalence Study of Olaparib Tablets Under Fasting and Fed Conditions in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2024-04
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 Study is a Randomized Open-Label 2-formulation Single-Dose 2-Period Crossover Bioequivalence Study with a washout period of 7 days During each session the subjects were administered a single dose of 100 mg Olaparib Tablets Test formulation or reference formulation under Fasting conditions or 150mg Olaparib Tablets Test formulation or reference formulation under Fasting and Fed conditions Venous blood samples were collected at pre-dose 0 h and up to 72 h post dose This study was to evaluate the bioequivalence and safety of the test formulation and the reference formulation of Olaparib Tablets in healthy subjects
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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?:
None