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

NCT06360445 | Completed Phase 1

• 1 other identifier: HD1912BE202201
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (3)

• Cmax Description: Maximum observed plasma concentration

  Cmax Description: Maximum observed plasma concentration

  Up to 72 hours post-dose for each period

• AUC0-∞ Description: Area under the plasma concentration time curve from time zero extrapolated to infinite time

  AUC0-∞ Description: Area under the plasma concentration time curve from time zero extrapolated to infinite time

  Up to 72 hours post-dose for each period

• AUC0-t Description: Area under the plasma concentration time curve from time zero to the time of the last quantifiable concentration

  AUC0-t Description: Area under the plasma concentration time curve from time zero to the time of the last quantifiable concentration

  Up to 72 hours post-dose for each period

Secondary Outcomes (5)

• Time of maximum observed plasma concentration (Tmax)

  Up to 72 hours post-dose for each period

• Terminal elimination half-life (T1/2)

  Up to 72 hours post-dose for each period

• Apparent total body clearance (Cl/F)

  Up to 72 hours post-dose for each period

• Apparent volume of distribution (V/F)

  Up to 72 hours post-dose for eachperiod

• Number of participants with Adverse Events

  Up to 10 days

Study Arms (6)

Olaparib Tablet test formulation 100mg

EXPERIMENTAL

Treatment A: During the study session, healthy subjects were administered a single dose of Olaparib Tablet test formulation100mg under Fasting conditions(test)

Drug: Olaparib Tablet test formulation 100mg

Olaparib Tablet reference formulation 100mg

ACTIVE COMPARATOR

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)

Drug: Olaparib Tablet reference formulation 100mg

Olaparib Tablet test formulation 150mg(fast)

EXPERIMENTAL

Treatment C: During the study session, healthy subjects were administered a single dose of Olaparib Tablet test formulation 150mg under Fasting conditions(test)

Drug: Olaparib Tablet test formulation 150mg

Olaparib Tablet reference formulation 150mg(fast)

ACTIVE COMPARATOR

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)

Drug: Olaparib Tablet reference formulation 150mg

Olaparib Tablet test formulation 150mg(fed)

EXPERIMENTAL

Treatment E: During the study session, healthy subjects were administered a single dose of Olaparib Tablet test formulation 150mg under Fed conditions(test)

Drug: Olaparib Tablet test formulation 150mg

Olaparib Tablet reference formulation 150mg(fed)

ACTIVE COMPARATOR

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)

Drug: Olaparib Tablet reference formulation 150mg

Interventions

Olaparib Tablet test formulation 100mg DRUG

A generic product manufactured by CSPC Ouyi Pharmaceutical Co., Ltd.

Olaparib Tablet test formulation 100mg

Olaparib Tablet reference formulation 100mg DRUG

Olaparib Tablet reference formulation 100mg were used as a comparator drug for the bioequivalence study, manufactured by AbbVie Limited.

Olaparib Tablet reference formulation 100mg

Olaparib Tablet test formulation 150mg DRUG

Olaparib Tablet reference formulation 150mg were used as a comparator drug for the bioequivalence study, manufactured by AbbVie Limited.

Olaparib Tablet test formulation 150mg(fast); Olaparib Tablet test formulation 150mg(fed)

Olaparib Tablet reference formulation 150mg DRUG

Olaparib Tablet reference formulation 150mg were used as a comparator drug for the bioequivalence study, manufactured by AbbVie Limited.

Olaparib Tablet reference formulation 150mg(fast); Olaparib Tablet reference formulation 150mg(fed)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Male only
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants were fully aware of the purpose, character, methodology, and possible adverse effects of the trial, and signed an informed consent form prior to the initiation of any research procedures;
• Healthy male aged 18 to 50 years old (including critical values);
• Weight equal to or more than 50.0 kg and body mass index between 19 to 26.0 kg/m\^2 (including critical values);
• Participants had no history of chronic or serious diseases, including cardiovascular, respiratory, gastrointestinal, urinary, hematologic and lymphatic, endocrine, immune, psychiatric, or neurological system diseases;
• Participants whose immediate family members had no breast, ovarian, pancreatic, prostate cancer, and other related diseases;
• Normal or abnormal results without clinical significance on all tests including vital signs, physical examination, laboratory evaluation (hematology, urinalysis, blood biochemistry, serology, coagulation function, and urine drug screening), 12-lead electrocardiogram, chest X-ray /Chest Computed Tomography (CCT) and alcohol breath test;
• Voluntarily signed the informed consent form, and cooperated in completing the trial according to the protocol.

You may not qualify if:

• Allergic constitution or allergic history to drugs or food;
• Participants with tablet swallowing distress;
• Participants with a history of surgery or trauma that may affect safety or in vivo metabolism of the drug, or who had undergone surgery within 1 year prior to screening or who were scheduled to undergo surgery during the trial;
• Participants who had used potent CYP 3A4 strong inhibitors, CYP 3A4 moderate inhibitors, CYP 3A4 strong inducers, and CYP 3A4 moderate inducers within 4 weeks prior to screening;
• Participants who had used p-gp inhibitors within 4 weeks prior to screening;
• Participants who had used any medicines or health products within 2 weeks prior to screening,
• Participants with a history of drug or substance abuse within 6 months prior to screening,or a positive urine drug test during screening;
• Participants who had used drugs within 3 months prior to screening;
• Smoking ≥ 5 cigarettes per day on average within 3 months prior to screening,or participants who could not stop using any tobacco-based products during the trial period;
• Participants who consumed more than 14 units of alcohol per week within the 3 months prior to screening, or who had a positive breath test for alcohol at screening,or who could not abstain from alcohol during the trial ;
• Participants who consumed excessive amounts of tea, coffee and/or caffeine-rich beverages per day within 3 months prior to screening
• Participants who had taken a special diet (dragon fruit, mango, grapefruit, lime, star fruit or food or drink prepared from them) within 7 days prior to screening, or participants who were unable to stop taking the above special diets during the trial;
• Participants who had participated in other clinical trials within 3 months prior to screening;
• Participants who had lost blood or donated more than 400 ml of blood or who had received blood transfusions or used blood products within 3 months prior to screening;
• Participants who cannot tolerate venipuncture or with a history of fainting needle or blood;

Sponsors & Collaborators

• CSPC Ouyi Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open label
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 2-period Crossover Assignment

Study Record Dates

• First Submitted: April 7, 2024
• First Posted: April 11, 2024
• Study Start: May 26, 2022
• Primary Completion: August 21, 2022
• Study Completion: August 21, 2022
• Last Updated: April 11, 2024

Record last verified: 2024-04

Locations

CN (1)