Bioequivalence Study of Olaparib Tablets Under Fasting and Fed Conditions in Healthy Subjects

Sponsor
CSPC Ouyi Pharmaceutical Co., Ltd.
Study ID
NCT06360445
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Participants

Eligibility Criteria

Sex
MALE
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

Study Details

This Study is a Randomized, Open-Label, 2-formulation, Single-Dose, 2-Period Crossover Bioequivalence Study with a washout period of 7 days. During each session, the subjects were administered a single dose of 100 mg Olaparib Tablets (Test formulation or reference formulation ) under Fasting conditions or 150mg Olaparib Tablets (Test formulation or reference formulation ) under Fasting and Fed conditions. Venous blood samples were collected at pre-dose (0 h), and up to 72 h post dose. This study was to evaluate the bioequivalence and safety of the test formulation and the reference formulation of Olaparib Tablets in healthy subjects.

Key Dates

Start date
May 26, 2022
Status verified
Apr 2024
Primary completion
Aug 21, 2022
Completion
Aug 21, 2022

Study Design

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

Arms

  • Experimental: Olaparib Tablet test formulation 100mg
    Treatment A: During the study session, healthy subjects were administered a single dose of Olaparib Tablet test formulation100mg under Fasting conditions(test)
  • Active Comparator: Olaparib Tablet reference formulation 100mg
    Treatment B: During the study session, healthy subjects were administered a single dose of Olaparib Tablet reference formulation 100mg under Fasting conditions(reference for Treatment A)
  • Experimental: Olaparib Tablet test formulation 150mg(fast)
    Treatment C: During the study session, healthy subjects were administered a single dose of Olaparib Tablet test formulation 150mg under Fasting conditions(test)
  • Active Comparator: Olaparib Tablet reference formulation 150mg(fast)
    Treatment D: During the study session, healthy subjects were administered a single dose of Olaparib Tablet reference formulation 150mg under Fasting conditions(reference for Treatment C)
  • Experimental: Olaparib Tablet test formulation 150mg(fed)
    Treatment E: During the study session, healthy subjects were administered a single dose of Olaparib Tablet test formulation 150mg under Fed conditions(test)
  • Active Comparator: Olaparib Tablet reference formulation 150mg(fed)
    Treatment F: During the study session, healthy subjects were administered a single dose of Olaparib Tablet reference formulation 150mg under Fed conditions(reference for Treatment E)

Primary Outcome Measure

Cmax Description: Maximum observed plasma concentration [ Time Frame: Up to 72 hours post-dose for each period ]

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