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

Sponsor
Sandoz
Study ID
NCT05258747
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Apr 7, 2022
Status verified
Jun 2024
Primary completion
Oct 20, 2022
Completion
Oct 20, 2022

Study Design

Enrollment
70 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Other: Olaparib tablets, 150 mg, then Lynparza® (olaparib) tablets 150 mg
    participants will receive 2 x 150 mg Olaparib tablets twice daily for 16 days in a crossover design
  • Other: Lynparza® (olaparib) tablets 150 mg, then Olaparib tablets, 150 mg
    participants will receive 2 x 150 mg Olaparib tablets twice daily for 16 days in a crossover design

Primary Outcome Measure

Maximum Plasma Concentration During the Dosing Interval at Steady State (CmaxSS) [ Time Frame: Pre-dose (0.00 hr) on day 1,6,7,8,14,15 and 16 and Post-dose on day 8 and day 16 ]

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