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

Phase 1

• Conditions: Healthy Volunteers
• Interventions: Drug: test-anastrozole tablet (Salutas Pharma GmbH); Drug: reference-anastrozole tablet

• Registration Number: NCT04445922
• Lead Sponsor: The Affiliated Hospital of Qingdao University

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.

Study Timeline

• Status Verified: 2020-06
• Study First Submitted: 2020-06-22
• Study First Submitted QC: 2020-06-22
• Study First Posted: 2020-06-24
• Last Update Submitted: 2020-06-27
• Last Update Posted: 2020-06-30
• Study Start: 2020-07-04
• Primary Completion: 2020-08-03
• Study Completion: 2020-10-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 26

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
test-anastrozole tablet	test-anastrozole tablet (Salutas Pharma GmbH)	1 mg anastrozole was produced and provided by Salutas Pharma GmbH
reference-anastrozole tablet	reference-anastrozole tablet	1 mg anastrozole was produced by AstraZeneca Pharmaceuticals LP.

Primary Outcome Measures

Name	Time	Method
the ratios of geometrical mean	60 days	The two preparations were considered bioequivalent if the 90% CIs of the ratios of the primary pharmacokinetics parameters were within the predefined acceptance range of 80%-125%.

Trial Locations

Locations (1)

Phase I Clinical Research Center; 🇨🇳 Qingdao, Shandong, China