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

Healthy Participants Clinical Trial

Official title:

A Randomized, Open-Label, 2-formulation, Single-Dose, 2-Period Crossover Bioequivalence Study of Olaparib Tablets Under Fasting and Fed Conditions in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06360445
• Other study ID #: HD1912BE202201
• Status: Completed
• Phase: Phase 1
• Start date: May 26, 2022
• Est. completion date: August 21, 2022

Study information

• Verified date: April 2024
• Source: CSPC Ouyi Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: August 21, 2022
• Est. primary completion date: August 21, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• Olaparib Tablet test formulation 100mg
A generic product manufactured by CSPC Ouyi Pharmaceutical Co., Ltd.
• Olaparib Tablet reference formulation 100mg
Olaparib Tablet reference formulation 100mg were used as a comparator drug for the bioequivalence study, manufactured by AbbVie Limited.
• Olaparib Tablet test formulation 150mg
Olaparib Tablet reference formulation 150mg were used as a comparator drug for the bioequivalence study, manufactured by AbbVie Limited.
• Olaparib Tablet reference formulation 150mg
Olaparib Tablet reference formulation 150mg were used as a comparator drug for the bioequivalence study, manufactured by AbbVie Limited.

Locations

Country	Name	City	State
China	Beijing Friendship Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
CSPC Ouyi Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax Description: Maximum observed plasma concentration	Cmax Description: Maximum observed plasma concentration	Up to 72 hours post-dose for each period
Primary	AUC0-8 Description: Area under the plasma concentration time curve from time zero extrapolated to infinite time	AUC0-8 Description: Area under the plasma concentration time curve from time zero extrapolated to infinite time	Up to 72 hours post-dose for each period
Primary	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	Time of maximum observed plasma concentration (Tmax)	Time of maximum observed plasma concentration (Tmax)	Up to 72 hours post-dose for each period
Secondary	Terminal elimination half-life (T1/2)	Terminal elimination half-life (T1/2)	Up to 72 hours post-dose for each period
Secondary	Apparent total body clearance (Cl/F)	Apparent total body clearance (Cl/F)	Up to 72 hours post-dose for each period
Secondary	Apparent volume of distribution (V/F)	Apparent volume of distribution (V/F)	Up to 72 hours post-dose for eachperiod
Secondary	Number of participants with Adverse Events	Number of participants with Adverse Events	Up to 10 days