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NCT06360445

Bioequivalence Study of Olaparib Tablets Under Fasting and Fed Conditions in Healthy Subjects

A Randomized, Open-Label, 2-formulation, Single-Dose, 2-Period Crossover Bioequivalence Study of Olaparib Tablets Under Fasting and Fed Conditions in Healthy Subjects
CSPC Ouyi Pharmaceutical Co., Ltd.·Phase 1·ClinicalTrials.gov·drugCompleted
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Study focus
Disease/Condition
Healthy Participants
Drug/Device/Intervention
Olaparib Tablet test formulation 100mg
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
CSPC Ouyi Pharmaceutical Co., Ltd.
Location
Beijing, China
Timeline & enrollment
Phase
Phase 1
Start date
May 26, 2022
End date
Aug 21, 2022
Enrollment
102 participants
Primary outcome

Cmax Description: Maximum observed plasma concentration,AUC0-∞ Description: Area under the plasma concentration time curve from time zero extrapolated to infinite time,AUC0-t Description: Area under the plasma concentration time curve from time zero to the time of the last quantifiable concentration

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.

ICD-10 classifications
Seeking and accepting physical, nutritional and chemical interventions known to be hazardous and harmfulHealthy person accompanying sick personRoutine general health check-up of sports teamsObesityPersons with potential health hazards related to communicable diseases
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06360445
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06360445 through Pure Global AI's free database. This Phase 1 trial is sponsored by CSPC Ouyi Pharmaceutical Co., Ltd. and is currently Completed. The study focuses on Healthy Participants. Target enrollment is 102 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.