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

C

CSPC Pharmaceutical Group

Status and phase

Completed
Phase 1

Conditions

Healthy Participants

Treatments

Drug: Olaparib Tablet test formulation 150mg
Drug: Olaparib Tablet test formulation 100mg
Drug: Olaparib Tablet reference formulation 150mg
Drug: Olaparib Tablet reference formulation 100mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT06360445
HD1912BE202201

Details and patient eligibility

About

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.

Enrollment

102 patients

Sex

Male

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

102 participants in 6 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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