Bioequivalence Study of Two Olaparib Tablets in Patients With Cancers

Sponsor
Qilu Pharmaceutical Co., Ltd.
Study ID
NCT05860530
Status
Completed

Conditions

  • Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

This study aimed to evaluate the pharmacokinetic characteristics and bioequivalence of two olaparib tablets in patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Key Dates

Start date
May 10, 2021
Status verified
May 2023
Primary completion
Sep 8, 2021
Completion
Sep 8, 2021

Study Design

Enrollment
48 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Other: Test-reference
    Administration order: The test olaparib tablets for 7 days, then the reference olaparib tablets for 7 days.
  • Other: Reference-test
    Administration order: The reference olaparib tablets for 7 days, then the test olaparib tablets for 7 days.

Primary Outcome Measure

Cmax,ss [ Time Frame: Day 7 ]

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