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

NCT ID: NCT06360445

Last Updated: 2024-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-26
• Study Completion Date: 2022-08-21

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

Olaparib Tablet test formulation 100mg

Intervention Type: DRUG

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

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)

Group Type: ACTIVE_COMPARATOR

Olaparib Tablet reference formulation 100mg

Intervention Type: DRUG

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

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)

Group Type: EXPERIMENTAL

Olaparib Tablet test formulation 150mg

Intervention Type: 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)

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)

Group Type: ACTIVE_COMPARATOR

Olaparib Tablet reference formulation 150mg

Intervention Type: 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(fed)

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

Group Type: EXPERIMENTAL

Olaparib Tablet test formulation 150mg

Intervention Type: 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(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)

Group Type: ACTIVE_COMPARATOR

Olaparib Tablet reference formulation 150mg

Intervention Type: DRUG

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

Interventions

Olaparib Tablet test formulation 100mg

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

Intervention Type: DRUG

Olaparib Tablet reference formulation 100mg

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

Intervention Type: DRUG

Olaparib Tablet test formulation 150mg

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

Intervention Type: DRUG

Olaparib Tablet reference formulation 150mg

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. 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;

2. Healthy male aged 18 to 50 years old (including critical values);

3. Weight equal to or more than 50.0 kg and body mass index between 19 to 26.0 kg/m^2 (including critical values);

4. Participants had no history of chronic or serious diseases, including cardiovascular, respiratory, gastrointestinal, urinary, hematologic and lymphatic, endocrine, immune, psychiatric, or neurological system diseases;

5. Participants whose immediate family members had no breast, ovarian, pancreatic, prostate cancer, and other related diseases;

6. 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;

7. Voluntarily signed the informed consent form, and cooperated in completing the trial according to the protocol.

Exclusion Criteria

1. Allergic constitution or allergic history to drugs or food;

2. Participants with tablet swallowing distress;

3. 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;

4. 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;

5. Participants who had used p-gp inhibitors within 4 weeks prior to screening;

6. Participants who had used any medicines or health products within 2 weeks prior to screening,

7. Participants with a history of drug or substance abuse within 6 months prior to screening,or a positive urine drug test during screening;

8. Participants who had used drugs within 3 months prior to screening;

9. 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;

10. 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 ;

11. Participants who consumed excessive amounts of tea, coffee and/or caffeine-rich beverages per day within 3 months prior to screening

12. 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;

13. Participants who had participated in other clinical trials within 3 months prior to screening;

14. 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;

15. Participants who cannot tolerate venipuncture or with a history of fainting needle or blood;

16. Participants who are lactose intolerant;

17. Participants with special dietary requirements who could not accept a uniform diet;

18. Participants who were planning to have children, unwilling or unable to use effective contraception, or had a plan to donate sperm from 2 weeks prior to the screening until 6 months after the last dose of study drug, and who were unwilling to use non-pharmacological contraception from 2 weeks prior to the screening until one month after the last dose of study drug;

19. Any condition that the investigator considered inappropriate for participation in the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

CSPC Ouyi Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

HD1912BE202201

Identifier Type: -

Identifier Source: org_study_id