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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Sandoz · Industry
• Sex: Female
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This is a two-way crossover bioequivalence study between test and reference product in patients diagnosed with BRCA mutated ovarian cancer, recurrent ovarian cancer or metastatic breast cancer.

Detailed description

This is a two-way crossover bioequivalence study between test and reference product in patients diagnosed with BRCA mutated ovarian cancer, recurrent ovarian cancer or metastatic breast cancer. Patients will be enrolled after providing written informed consent and treatments will be allocated to patient by carrying out randomization using statistical techniques. Patients that are already on a stable dose of Lynparza® (olaparib) tablets and have met the eligibility criteria will be directly randomized for participation in the study. After randomization patients will receive either test or reference product in a crossover manner based on the randomization schedule. Patients will receive the dose of 300 mg twice daily for 16 days in a crossover design. In period-I (Day 1 to Day 8), patients will receive either Test product or Reference product for 8 days based on the randomization schedule. In period-II (Day 9 to Day 16), patients will be switched to the other product for a second period of 8 days.

Conditions

• Ovarian Cancer
• Breast Cancer

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2022-04-07
• Primary completion: 2022-10-20
• Completion: 2022-10-20
• First posted: 2022-02-28
• Last updated: 2024-10-03
• Results posted: 2024-10-03

Locations

1 site across 1 country: India

Regulatory

• FDA-regulated drug study