Bioequivalence of Oral Formulations of Anastrozole in Healthy Chinese Volunteers Under Fed Condition

NCT ID: NCT04445922

Last Updated: 2020-06-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-04
• Study Completion Date: 2020-10-30

Brief Summary

An open-label, randomized, two-period, two-group, crossover study was conducted in 26 healthy Chinese volunteers under fed conditions to assess the bioequivalence between two formulations of Anastrozole.

Detailed Description

Anastrozole is currently used as first-line treatment in locally advanced or metastatic breast cancer. A generic anastrozole tablet was developed to offer an alternative to the marketed tablet formulation.The aim of the current study was to evaluate the bioequivalence between the test and reference formulations of anastrozole in a single-dose, 2-period, 2-sequence crossover study with a 21-day washout interval. A total of 26 healthy Chinese female subjects were randomized to receive a single dose of 1.0-mg test and reference formulations of anastrozole within 30 min after beginning the consumption of a recommended high-fat, high-calorie breakfast (150 calories from protein, 250 calories from carbohydrate, and 500-600 calories from fat; total calories approximately 800-1000).This was repeated two times, separated by a 21-day washout period.Blood samples (3 mL) for pharmacokinetic analysis were collected predose and 20min, 40min, 1, 1.5, 2, 2h20min, 2h40min, 3, 3.5, 4, 4.5, 5, 7, 12, 24, 48 and 72 hours postdose and were determined by a fully validated high-pressure liquid chromatography-tandem mass spectrometry method. The evaluated pharmacokinetic parameters, including Cmax, AUC0-t, AUC0-∞,were assessed for bioequivalence based on current guidelines.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

test-anastrozole tablet

1 mg anastrozole was produced and provided by Salutas Pharma GmbH

Group Type: EXPERIMENTAL

test-anastrozole tablet (Salutas Pharma GmbH)

Intervention Type: DRUG

Subjects were allocated to one of two groups randomly and equally with a 21-day washout interval between the two periods.All of them were randomized (1:1) to receive anastrozole as a single oral dose of the test drug or a single 1.0-mg oral dose of Arimidex

reference-anastrozole tablet

1 mg anastrozole was produced by AstraZeneca Pharmaceuticals LP.

Group Type: EXPERIMENTAL

reference-anastrozole tablet

Intervention Type: DRUG

Subjects were allocated to one of two groups randomly and equally with a 21-day washout interval between the two periods.All of them were randomized (1:1) to receive anastrozole as a single oral dose of the test drug or a single 1.0-mg oral dose of Arimidex

Interventions

test-anastrozole tablet (Salutas Pharma GmbH)

Subjects were allocated to one of two groups randomly and equally with a 21-day washout interval between the two periods.All of them were randomized (1:1) to receive anastrozole as a single oral dose of the test drug or a single 1.0-mg oral dose of Arimidex

Intervention Type: DRUG

reference-anastrozole tablet

Subjects were allocated to one of two groups randomly and equally with a 21-day washout interval between the two periods.All of them were randomized (1:1) to receive anastrozole as a single oral dose of the test drug or a single 1.0-mg oral dose of Arimidex

Intervention Type: DRUG

Other Intervention Names

Arimidex

Eligibility Criteria

Inclusion Criteria

• Healthy Postmenopausal volunteers aged between 18 and 65 years old.
• The body mass index is in the range of 19.0-28.0 kg/m2 (including the critical value). The weight is not less than 45 kg.
• The subjects have no family planning within 6 months and could select contraceptive method.
• Subjects who had not any medical history of cardiovascular, digestive, respiratory, nervous, haemal diseases or hepatic/renal impairment.

Exclusion Criteria

• Meet the diagnostic criteria for osteoporosis.
• Subjects with vaginal bleeding.
• blood donation, massive blood loss (#400mL) or enrolled in other clinical trials 3 months prior to screening.
• any use of other prescription drugs (including contraceptive) 28 days prior to medication for this study.
• any history of alcohol abuse in the recent 2 years or moderate drinkers (drink more 2 units per day or 14 units per week);
• smoking more than 5 cigarettes per day during the 3 months prior to screening;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

The Affiliated Hospital of Qingdao University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yu Cao, doctor

Role: PRINCIPAL_INVESTIGATOR

the study director of phase I clinical research center

Locations

Phase I Clinical Research Center

Qingdao, Shandong, China

Countries

China

Central Contacts

Yu Cao, doctor

Role: CONTACT

Phone: 86 18661809090

Email: caoyu1767@126.com

Ye Tao, master

Role: CONTACT

Phone: 86 17853287551

Email: taoye165298765@163.com

Other Identifiers

TG1915ANA

Identifier Type: -

Identifier Source: org_study_id