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Clinical trial

A Randomized, Open Label, Multi-centre, Two-treatment, Two-period, Two-sequence, Two-stage, Multiple Dose, Steady-state, Crossover, Bioequivalence Study of Olaparib Tablets, 150 mg (Lek Pharmaceuticals d.d.) and Lynparza® (Olaparib) Tablets 150 mg (AstraZeneca Pharmaceuticals LP), in Patients With BRCA Mutated Ovarian Cancer, Recurrent Ovarian Cancer or Metastatic Breast Cancer Under Fasting Condition

NCT05258747 is registered in ClinicalTrials.gov with Sandoz as lead sponsor.

NCT NCT05258747
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Registry record

As filed in ClinicalTrials.gov.

Title
A Randomized, Open Label, Multi-centre, Two-treatment, Two-period, Two-sequence, Two-stage, Multiple Dose, Steady-state, Crossover, Bioequivalence Study of Olaparib Tablets, 150 mg (Lek Pharmaceuticals d.d.) and Lynparza® (Olaparib) Tablets 150 mg (AstraZeneca Pharmaceuticals LP), in Patients With BRCA Mutated Ovarian Cancer, Recurrent Ovarian Cancer or Metastatic Breast Cancer Under Fasting Condition
Lead sponsor
Sandoz
Phase
Phase 1
Overall status
Completed
Start date
April 7, 2022
Completion date
October 20, 2022
Enrollment
70 (actual)
Sites
1

Conditions

As the registry lists them; a condition with its own page is linked.

breast cancer, ovarian cancer