At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 70 enrolled
Drug / intervention
Olaparib tablets, 150 mg +1 moredrug
Likely dose
Olaparib tablets, 150 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating Olaparib tablets, 150 mg and Lynparza® (olaparib) tablets 150 mg for Ovarian Cancer and Breast Cancer. Completed, enrolled 70 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOvarian Cancer, Breast Cancer
CountriesIndia
Collaborators--
Timeline
Phase 1CompletedFinished
2023202420252026
First PostedFeb 2022
Enrollment StartApr 2022
Primary CompletionOct 2022
TodayJul 2026
First PostedFeb 28, 2022
Enrollment StartApr 7, 2022
Primary CompletionOct 20, 2022
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 4.3 years ago
Interventions
Olaparib tablets, 150 mgdrug
Olaparib tablets, 150 mg of Lek Pharmaceuticals d.d., Slovenia
Lynparza® (olaparib) tablets 150 mgdrug
Lynparza® (olaparib) tablets 150 mg Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington, Delaware (DE).