Healthy VolunteersPhase 1NCT04863105
Bioequivalence of Abiraterone Acetate Tablets in Healthy Chinese Volunteers
A Phase 1 study testing Abiraterone acetate tablets(Zecke ®250 mg);Abiraterone acetate tablets(250 mg) in people with Healthy Volunteers, run by The Affiliated Hospital of Qingdao University at 1 site in China.
Trial summary
An open, randomized, single-dose, three-cycle, three-sequence crossover study was conducted in 36 healthy volunteers under fasting condition to evaluate the bioequivalence of two abiratone acetate tablets. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Abiraterone acetate tablets(Zecke ®250 mg);Abiraterone acetate tablets(250 mg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 24 Nov 2017to 9 Apr 2018
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects above 18 years old (including 18 years old).
- Weight not less than 50 kg, body mass index between 19 and 28kg/m2.
- No bad habits such as smoking or alcohol, and no history of drug abuse.
- Subjects are willing to have no birth plan in the next 6 months and voluntarily take effective contraceptive measures.
- Volunteered to participate in the clinical trial, understood the study procedures and signed the written informed consent. Able to complete the study according to the test protocol.
Who cannot join
- Abnormal results of vital signs, physical examination, electrocardiogram and other laboratory examinations were clinically significant.
- With the central nervous system, cardiovascular system, liver and kidney function is not complete, the digestive system (not included in the drug delivery two weeks ago suffering from acute gastroenteritis, diarrhea), respiratory system (not included in the drug delivery two weeks ago with upper respiratory infection), metabolism and skeletal system disease, or any other may affect the results of the study of disease and physiological conditions.
- A history of hospitalization or surgery within 3 months prior to the trial.
- Known active hepatitis B, HIV, HCV and Treponema pallidum infection.
- Have a history of specific allergic reactions (such as atopic dermatitis, asthma, etc.), or have a history of allergy to drugs and biological agents, or have a history of known allergy to the ingredients of this drug.
- Positive alcohol and urine drug screening.
Show all 15Show fewer
- Regular drinkers who consumed more than 14 units of alcohol per week (1 unit is 360 mL beer or 45 mL liquor of 40% alcohol or 150 mL wine) during the 3 months prior to the trial.
- Smoking more than 5 cigarettes per day within 3 months before the trial.
- Participate as a subject in any drug clinical trial within 3 months prior to the trial.
- People who had donated blood or lost more than 400mL of blood in 3 months before the experiment.
- Have taken any prescription drugs during the 14 days prior to the trial. Have taken any over-the-counter medicines, any functional vitamins or herbal products within 48 hours prior to the trial.
- Have consumed any xanthine-rich beverage or food or grapefruit fruit or products containing grapefruit within 48 hours prior to the test.
- Have consumed any food or drink containing caffeine (such as tea or coffee) and any alcoholic products within 48 hours before the trial.
- Have special requirements on diet and fail to follow the diet and corresponding regulations provided.
- Subjects who are considered by the investigator to have poor compliance or have any unsuitable factors for participating in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bioequivalence of Abiraterone Acetate in Healthy Chinese Volunteers: an Open, Randomized, Single-dose, Three-cycle, Three-sequence Crossover Study
An open, randomized, single-dose, three-cycle, three-sequence crossover study was conducted in 36 healthy volunteers under fasting condition to evaluate the bioequivalence of two abiratone acetate tablets.
Read the detailed description
Abiraterone acetate tablet is an androgen synthesis inhibitor, primarily for the treatment of mCRPC. The objective of this study was to evaluate the pharmacokinetics and bioequivalence of two abiraterone acetate tablets in healthy Chinese subjects. In healthy subjects, a single-center, open, single-dose, randomized, three-cycle, three-sequence, semi-repeat (duplicate reference preparation only), reference formulation corrected fasting mean bioequivalence trial was conducted with a minimum of 7 days cleaning period between dosing.
Blood samples were collected at prescribed time intervals, and the plasma concentration of abiraterone acetate tablet was determined by liquid chromatography-tandem mass spectrometry and adverse events were recorded.
The pharmacokinetic parameters Cmax, Tmax, AUC0-t, AUC0-∞, T1/2 and so on were calculated by non-atrioventricular model. When the individual coefficient of variation(CVWR) of the pharmacokinetic parameters (AUC0-t, AUC0-∞ and Cmax) of reference formulation was less than 30%,with an average bioequivalence (ABE) criterion: if the test formulation and reference formulation of pharmacokinetic parameters (AUC0 - t,AUC0-∞ and Cmax) of the 90% CIs of GMR is not beyond the range of 80.00% -125.00%, which can determine the test formulation and reference formulation have bioequivalence.When the CVWR of the pharmacokinetic parameters (AUC0-t, AUC0-∞ and Cmax) of the reference preparation is greater than or equal to 30%,the reference preparation was used to correct for mean bioequivalence (RSABE): if the critbound of the pharmacokinetic parameters (AUC0-t,AUC0-∞ , Cmax) of the test formulations and reference formulations is less than 0, and the geometric average ratio is not beyond the range of 0.8000 - 1.2500, which can determine the test formulation and reference formulation have bioequivalence.
- Conditions
- Healthy Volunteers
- Being tested
- Abiraterone acetate tablets(Zecke ®250 mg);Abiraterone acetate tablets(250 mg)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abiraterone acetate tablets(Zecke ®250 mg);Abiraterone acetate tablets(250 mg)Drug
Subjects were allocated to one of three groups randomly and equally with a 7-day washout interval between the two periods."Abiraterone acetate tablets(Zecke ® 250 mg,Batch number:VYCB manufactured by Patheon Inc.)and Abiraterone acetate tablets(250 mg,Batch number:17F0023DD9 manufactured by Qilu Pharmaceutical Co., Ltd) were used in this study.
| Study group | Role | What they receive |
|---|---|---|
| Conference-Abiraterone acetate tablet | Experimental | Abiraterone acetate tablets(Zecke ® 250 mg,Batch number:VYCB manufactured by Patheon Inc.) Receives: Drug: Abiraterone acetate tablets(Zecke ®250 mg);Abiraterone acetate tablets(250 mg) |
| test-Abiraterone acetate tablet | Experimental | Abiraterone acetate tablets(250 mg,Batch number:17F0023DD9 manufactured by Qilu Pharmaceutical Co., Ltd) Receives: Drug: Abiraterone acetate tablets(Zecke ®250 mg);Abiraterone acetate tablets(250 mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
the ratios of geometrical mean
The two formulations are considered to be bioequivalent if the CVWR is less than 30% and 90% CIS of the ratio of primary pharmacokinetic parameters is within a predetermined acceptance range of 80% to 125%. If the CVWR of the pharmacokinetic parameters of the reference preparation is greater than or equal to 30%, Critbound ≤0, and the geometric mean ratio does not exceed the range of 0.8000 to 1.2500, the test preparation and the reference preparation can be determined to be bioequivalent.
Measured: 30 Days
Secondary outcomes (1)
the occurrence rate of adverse events
Adverse events were recorded to evaluate the safety of the studied drugs.
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study start24 Nov 2017
- Primary completion25 Dec 2017
- Study completion9 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by The Affiliated Hospital of Qingdao UniversityThe 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
- an open, randomized, single-dose, three-cycle, three-sequence crossover study
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu Cao, Doctor, Principal investigator, the study director of phase I clinical research center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04863105
- Sponsor's protocol ID
- QL-YK4-047-001
- Status last verified
- Apr 2021
- First submitted
- 23 Mar 2021
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All the technical achievements and outcomes of this trial are owned by Qilu Pharmaceutical Co., Ltd. and the research center. The research center can not publish any academic papers without the consent of the sponsor.
Publications
Wu ZX, Wang CJ, Shi P, Liu YP, Li T, Sun FF, Fu Y, Gao XM, Ma YP, Cao Y. Pharmacokinetics and Bioequivalence of Abiraterone Acetate Tablets in Healthy Chinese Volunteers: An Open, Randomized, Single-Dose, Three-Period, Three-Sequence Crossover Study. Drugs R D. 2023 Jun;23(2):121-127. doi: 10.1007/s40268-023-00418-6. Epub 2023 Apr 3.
PubMed 37012461
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence of Abiraterone Acetate in Healthy Chinese Volunteers: an Open, Randomized, Single-dose, Three-cycle, Three-sequence Crossover Study
- ClinicalTrials.gov ID
- NCT04863105
- Acronym / sponsor ID
- QL-YK4-047-001
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
- Study start
- 24 Nov 2017 (actual)
- Primary completion
- 25 Dec 2017 (actual)
- Study completion
- 9 Apr 2018 (actual)
- First posted
- 28 Apr 2021 (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.
An open, randomized, single-dose, three-cycle, three-sequence crossover study was conducted in 36 healthy volunteers under fasting condition to evaluate the bioequivalence of two abiratone acetate tablets.
Detailed description
Abiraterone acetate tablet is an androgen synthesis inhibitor, primarily for the treatment of mCRPC. The objective of this study was to evaluate the pharmacokinetics and bioequivalence of two abiraterone acetate tablets in healthy Chinese subjects. In healthy subjects, a single-center, open, single-dose, randomized, three-cycle, three-sequence, semi-repeat (duplicate reference preparation only), reference formulation corrected fasting mean bioequivalence trial was conducted with a minimum of 7 days cleaning period between dosing.
Blood samples were collected at prescribed time intervals, and the plasma concentration of abiraterone acetate tablet was determined by liquid chromatography-tandem mass spectrometry and adverse events were recorded.
The pharmacokinetic parameters Cmax, Tmax, AUC0-t, AUC0-∞, T1/2 and so on were calculated by non-atrioventricular model. When the individual coefficient of variation(CVWR) of the pharmacokinetic parameters (AUC0-t, AUC0-∞ and Cmax) of reference formulation was less than 30%,with an average bioequivalence (ABE) criterion: if the test formulation and reference formulation of pharmacokinetic parameters (AUC0 - t,AUC0-∞ and Cmax) of the 90% CIs of GMR is not beyond the range of 80.00% -125.00%, which can determine the test formulation and reference formulation have bioequivalence.When the CVWR of the pharmacokinetic parameters (AUC0-t, AUC0-∞ and Cmax) of the reference preparation is greater than or equal to 30%,the reference preparation was used to correct for mean bioequivalence (RSABE): if the critbound of the pharmacokinetic parameters (AUC0-t,AUC0-∞ , Cmax) of the test formulations and reference formulations is less than 0, and the geometric average ratio is not beyond the range of 0.8000 - 1.2500, which can determine the test formulation and reference formulation have bioequivalence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- an open, randomized, single-dose, three-cycle, three-sequence crossover study
| Arm | Type | Receives |
|---|---|---|
| Conference-Abiraterone acetate tablet | Experimental | Drug: Abiraterone acetate tablets(Zecke ®250 mg);Abiraterone acetate tablets(250 mg)Abiraterone acetate tablets(Zecke ® 250 mg,Batch number:VYCB manufactured by Patheon Inc.) |
| test-Abiraterone acetate tablet | Experimental | Drug: Abiraterone acetate tablets(Zecke ®250 mg);Abiraterone acetate tablets(250 mg)Abiraterone acetate tablets(250 mg,Batch number:17F0023DD9 manufactured by Qilu Pharmaceutical Co., Ltd) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male subjects above 18 years old (including 18 years old).
- Weight not less than 50 kg, body mass index between 19 and 28kg/m2.
- No bad habits such as smoking or alcohol, and no history of drug abuse.
- Subjects are willing to have no birth plan in the next 6 months and voluntarily take effective contraceptive measures.
- Volunteered to participate in the clinical trial, understood the study procedures and signed the written informed consent. Able to complete the study according to the test protocol.
Key exclusion criteria (15 listed)
- Abnormal results of vital signs, physical examination, electrocardiogram and other laboratory examinations were clinically significant.
- With the central nervous system, cardiovascular system, liver and kidney function is not complete, the digestive system (not included in the drug delivery two weeks ago suffering from acute gastroenteritis, diarrhea), respiratory system (not included in the drug delivery two weeks ago with upper respiratory infection), metabolism and skeletal system disease, or any other may affect the results of the study of disease and physiological conditions.
- A history of hospitalization or surgery within 3 months prior to the trial.
- Known active hepatitis B, HIV, HCV and Treponema pallidum infection.
- Have a history of specific allergic reactions (such as atopic dermatitis, asthma, etc.), or have a history of allergy to drugs and biological agents, or have a history of known allergy to the ingredients of this drug.
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 |
|---|---|---|
| Abiraterone acetate tablets(Zecke ®250 mg);Abiraterone acetate tablets(250 mg)Subjects were allocated to one of three groups randomly and equally with a 7-day washout interval between the two periods."Abiraterone acetate tablets(Zecke ® 250 mg,Batch number:VYCB manufactured by Patheon Inc.)and Abiraterone acetate tablets(250 mg,Batch number:17F0023DD9 manufactured by Qilu Pharmaceutical Co., Ltd) were used in this study. | Drug | Conference-Abiraterone acetate tablet, test-Abiraterone acetate tablet |
Primary outcome
the ratios of geometrical mean
Time frame: 30 Days
The two formulations are considered to be bioequivalent if the CVWR is less than 30% and 90% CIS of the ratio of primary pharmacokinetic parameters is within a predetermined acceptance range of 80% to 125%. If the CVWR of the pharmacokinetic parameters of the reference preparation is greater than or equal to 30%, Critbound ≤0, and the geometric mean ratio does not exceed the range of 0.8000 to 1.2500, the test preparation and the reference preparation can be determined to be bioequivalent.
1 secondary outcome
the occurrence rate of adverse events
Time frame: 30 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 28 Apr 2021.
- Derived from this study: PubMed 37012461Wu ZX, Wang CJ, Shi P, Liu YP, Li T, Sun FF, Fu Y, Gao XM, Ma YP, Cao Y. Pharmacokinetics and Bioequivalence of Abiraterone Acetate Tablets in Healthy Chinese Volunteers: An Open, Randomized, Single-Dose, Three-Period, Three-Sequence Crossover Study. Drugs R D. 2023 Jun;23(2):121-127. doi: 10.1007/s40268-023-00418-6. Epub 2023 Apr 3.
- Individual participant dataSharing planned: No. All the technical achievements and outcomes of this trial are owned by Qilu Pharmaceutical Co., Ltd. and the research center. The research center can not publish any academic papers without the consent of the sponsor.
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Screening Protocol
Pain
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.
Yu Cao, Doctor principal investigator
the study director of phase I clinical research center
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 Abiraterone acetate tablets(Zecke ®250 mg);Abiraterone acetate tablets(250 mg) in people with Healthy Volunteers, run by The Affiliated Hospital of Qingdao University 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 5 inclusion and 15 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 28 Apr 2021. 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?
the ratios of geometrical mean (time frame: 30 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04863105, which also lists 1 linked publication.
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 28 Apr 2021.