NCT05258747View on ClinicalTrials.gov

A Crossover Bioequivalence Study of Olaparib Tablets, 150 mg (Lek Pharmaceuticals d.d.) and Lynparza® (Olaparib) Tablets 150 mg (AstraZeneca Pharmaceuticals LP), in Patients With Breast Cancer Gene (BRCA) Mutated Ovarian Cancer, Recurrent Ovarian Cancer or Metastatic Breast Cancer

PHASE1CompletedINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

April 7, 2022

Primary Completion Date

October 20, 2022

Study Completion Date

October 20, 2022

Conditions
Ovarian CancerBreast Cancer
Interventions
DRUG

Olaparib tablets, 150 mg

Olaparib tablets, 150 mg of Lek Pharmaceuticals d.d., Slovenia

DRUG

Lynparza® (olaparib) tablets 150 mg

Lynparza® (olaparib) tablets 150 mg Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington, Delaware (DE).

Trial Locations (1)

520002

Sandoz Investigative Site, Vijayawada

Sponsors

Lead Sponsor

Sandoz
All Listed Sponsors
lead

Sandoz

INDUSTRY

NCT05258747 - A Crossover Bioequivalence Study of Olaparib Tablets, 150 mg (Lek Pharmaceuticals d.d.) and Lynparza® (Olaparib) Tablets 150 mg (AstraZeneca Pharmaceuticals LP), in Patients With Breast Cancer Gene (BRCA) Mutated Ovarian Cancer, Recurrent Ovarian Cancer or Metastatic Breast Cancer | Biotech Hunter | Biotech Hunter