Bioequivalence Study of Olaparib Tablets Under Fasting and Fed Conditions in Healthy Subjects
Phase 1
Completed
- Conditions
- Healthy Participants
- Interventions
- Registration Number
- NCT06360445
- Lead Sponsor
- CSPC Ouyi Pharmaceutical Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 102
Inclusion Criteria
- 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.
Exclusion Criteria
- 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;
- Participants who are lactose intolerant;
- Participants with special dietary requirements who could not accept a uniform diet;
- 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;
- Any condition that the investigator considered inappropriate for participation in the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Olaparib Tablet test formulation 150mg(fed) Olaparib Tablet test formulation 150mg Treatment E: During the study session, healthy subjects were administered a single dose of Olaparib Tablet test formulation 150mg under Fed conditions(test) Olaparib Tablet reference formulation 150mg(fed) Olaparib Tablet reference formulation 150mg 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) Olaparib Tablet test formulation 150mg(fast) Olaparib Tablet test formulation 150mg Treatment C: During the study session, healthy subjects were administered a single dose of Olaparib Tablet test formulation 150mg under Fasting conditions(test) Olaparib Tablet reference formulation 150mg(fast) Olaparib Tablet reference formulation 150mg 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) Olaparib Tablet test formulation 100mg 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) Olaparib Tablet reference formulation 100mg 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)
- Primary Outcome Measures
Name Time Method 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 AUC0-t Description: Area under the plasma concentration time curve from time zero to the time of the last quantifiable concentration
Cmax Description: Maximum observed plasma concentration Up to 72 hours post-dose for each period Cmax Description: Maximum observed plasma concentration
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-∞ Description: Area under the plasma concentration time curve from time zero extrapolated to infinite time
- Secondary Outcome Measures
Name Time Method Terminal elimination half-life (T1/2) Up to 72 hours post-dose for each period Terminal elimination half-life (T1/2)
Apparent total body clearance (Cl/F) Up to 72 hours post-dose for each period Apparent total body clearance (Cl/F)
Time of maximum observed plasma concentration (Tmax) Up to 72 hours post-dose for each period Time of maximum observed plasma concentration (Tmax)
Apparent volume of distribution (V/F) Up to 72 hours post-dose for eachperiod Apparent volume of distribution (V/F)
Number of participants with Adverse Events Up to 10 days Number of participants with Adverse Events
Trial Locations
- Locations (1)
Beijing Friendship Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Beijing Friendship Hospital, Capital Medical University🇨🇳Beijing, Beijing, China