Bioequivalence of Abiraterone Acetate Tablets in Healthy Chinese Volunteers

NCT04863105 | Completed Phase 1 DMC

• 1 other identifier: QL-YK4-047-001
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• 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.

  30 Days

Secondary Outcomes (1)

• the occurrence rate of adverse events

  30 Days

Study Arms (2)

Conference-Abiraterone acetate tablet

EXPERIMENTAL

Abiraterone acetate tablets(Zecke ® 250 mg,Batch number:VYCB manufactured by Patheon Inc.)

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)

Drug: Abiraterone acetate tablets(Zecke ®250 mg);Abiraterone acetate tablets(250 mg)

Interventions

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.

Conference-Abiraterone acetate tablet; test-Abiraterone acetate tablet

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• The Affiliated Hospital of Qingdao University: lead

Study Sites (1)

Phase I Clinical Research Center

Qingdao, Shangdong, 266003, China

Location

Related Publications (1)

• 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.

  PMID: 37012461 DERIVED

Study Officials

• Yu Cao, Doctor

  the study director of phase I clinical research center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: an open, randomized, single-dose, three-cycle, three-sequence crossover study

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: April 28, 2021
• Study Start: November 24, 2017
• Primary Completion: December 25, 2017
• Study Completion: April 9, 2018
• Last Updated: April 28, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)