Healthy ParticipantsPhase 1NCT06360445
Bioequivalence Study of Olaparib Tablets Under Fasting and Fed Conditions in Healthy Subjects
A Phase 1 study testing Olaparib Tablet test formulation 100mg, Olaparib Tablet reference formulation 100mg and Olaparib Tablet test formulation 150mg in people with Healthy Participants, run by CSPC Ouyi Pharmaceutical Co., Ltd. at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Olaparib Tablet test formulation 100mg, Olaparib Tablet reference formulation 100mg and Olaparib Tablet test formulation 150mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteChina
- Study dates
- 26 May 2022to 21 Aug 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 19Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
About this study
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
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
- Being tested
- Olaparib Tablet test formulation 100mg, Olaparib Tablet reference formulation 100mg, Olaparib Tablet test formulation 150mg, Olaparib Tablet reference formulation 150mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olaparib Tablet test formulation 100mgDrug
A generic product manufactured by CSPC Ouyi Pharmaceutical Co., Ltd.
Olaparib Tablet reference formulation 100mgDrug
Olaparib Tablet reference formulation 100mg were used as a comparator drug for the bioequivalence study, manufactured by AbbVie Limited.
Olaparib Tablet test formulation 150mgDrug
Olaparib Tablet reference formulation 150mg were used as a comparator drug for the bioequivalence study, manufactured by AbbVie Limited.
Olaparib Tablet reference formulation 150mgDrug
Olaparib Tablet reference formulation 150mg were used as a comparator drug for the bioequivalence study, manufactured by AbbVie Limited.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: 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) Receives: 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) Receives: 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) Receives: 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) Receives: Drug: Olaparib Tablet reference formulation 150mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax Description: Maximum observed plasma concentration
Cmax Description: Maximum observed plasma concentration
Measured: 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
Measured: 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
Measured: Up to 72 hours post-dose for each period
Secondary outcomes (5)
Time of maximum observed plasma concentration (Tmax)
Time of maximum observed plasma concentration (Tmax)
Measured: Up to 72 hours post-dose for each period
Terminal elimination half-life (T1/2)
Terminal elimination half-life (T1/2)
Measured: Up to 72 hours post-dose for each period
Apparent total body clearance (Cl/F)
Apparent total body clearance (Cl/F)
Measured: Up to 72 hours post-dose for each period
Apparent volume of distribution (V/F)
Apparent volume of distribution (V/F)
Measured: Up to 72 hours post-dose for eachperiod
Number of participants with Adverse Events
Number of participants with Adverse Events
Measured: Up to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start26 May 2022
- Primary completion21 Aug 2022
- Study completion21 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by CSPC Ouyi Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 2-period Crossover Assignment
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- CSPC Ouyi Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06360445
- Sponsor's protocol ID
- HD1912BE202201
- Status last verified
- Apr 2024
- First submitted
- 7 Apr 2024
- Last updated
- 11 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06360445
- Acronym / sponsor ID
- HD1912BE202201
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- CSPC Ouyi Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 May 2022 (actual)
- Primary completion
- 21 Aug 2022 (actual)
- Study completion
- 21 Aug 2022 (actual)
- First posted
- 11 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- 2-period Crossover Assignment
| Arm | Type | Receives |
|---|---|---|
| Olaparib Tablet test formulation 100mg | Experimental | Drug: Olaparib Tablet test formulation 100mgTreatment 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 | Active comparator | Drug: Olaparib Tablet reference formulation 100mgTreatment 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) |
| Olaparib Tablet test formulation 150mg(fast) | Experimental | Drug: Olaparib Tablet test formulation 150mgTreatment 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) | Active comparator | Drug: Olaparib Tablet reference formulation 150mgTreatment 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 150mg(fed) | Experimental | Drug: Olaparib Tablet test formulation 150mgTreatment 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) | Active comparator | Drug: Olaparib Tablet reference formulation 150mgTreatment 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) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (19 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Olaparib Tablet test formulation 100mgA generic product manufactured by CSPC Ouyi Pharmaceutical Co., Ltd. | Drug | Olaparib Tablet test formulation 100mg |
| Olaparib Tablet reference formulation 100mgOlaparib Tablet reference formulation 100mg were used as a comparator drug for the bioequivalence study, manufactured by AbbVie Limited. | Drug | Olaparib Tablet reference formulation 100mg |
| Olaparib Tablet test formulation 150mgOlaparib Tablet reference formulation 150mg were used as a comparator drug for the bioequivalence study, manufactured by AbbVie Limited. | Drug | Olaparib Tablet test formulation 150mg(fast), Olaparib Tablet test formulation 150mg(fed) |
| Olaparib Tablet reference formulation 150mgOlaparib Tablet reference formulation 150mg were used as a comparator drug for the bioequivalence study, manufactured by AbbVie Limited. | Drug | Olaparib Tablet reference formulation 150mg(fast), Olaparib Tablet reference formulation 150mg(fed) |
Primary outcome
Cmax Description: Maximum observed plasma concentration
Time frame: 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
Time frame: 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-t Description: Area under the plasma concentration time curve from time zero to the time of the last quantifiable concentration
Time frame: 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
5 secondary outcomes
Time of maximum observed plasma concentration (Tmax)
Time frame: Up to 72 hours post-dose for each period
Terminal elimination half-life (T1/2)
Time frame: Up to 72 hours post-dose for each period
Apparent total body clearance (Cl/F)
Time frame: Up to 72 hours post-dose for each period
Apparent volume of distribution (V/F)
Time frame: Up to 72 hours post-dose for eachperiod
Number of participants with Adverse Events
Time frame: Up to 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Olaparib Tablet test formulation 100mg, Olaparib Tablet reference formulation 100mg and Olaparib Tablet test formulation 150mg in people with Healthy Participants, run by CSPC Ouyi Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax Description: Maximum observed plasma concentration (time frame: Up to 72 hours post-dose for each period). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2024.