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

Bioequivalence of Oral Formulations of Anastrozole in Healthy Chinese Volunteers Under Fed Condition: A Open-label, Randomized,Single- Dose,Two-period, Two-group, Crossover Study

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.

Study Overview

• Status: Unknown
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: test-anastrozole tablet (Salutas Pharma GmbH); Drug: reference-anastrozole tablet

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 Type: Interventional
• Enrollment (Anticipated): 26
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shandong
    • Qingdao, Shandong, China, 266003
      • Phase I Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: test-anastrozole tablet; 1 mg anastrozole was produced and provided by Salutas Pharma GmbH	Drug: 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
EXPERIMENTAL: reference-anastrozole tablet; 1 mg anastrozole was produced by AstraZeneca Pharmaceuticals LP.	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; Other Names: Arimidex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the ratios of geometrical mean	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%.	60 days

Collaborators and Investigators

• Sponsor: The Affiliated Hospital of Qingdao University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 4, 2020
• Primary Completion (ANTICIPATED): August 3, 2020
• Study Completion (ANTICIPATED): October 30, 2020

Study Registration Dates

• First Submitted: June 22, 2020
• First Submitted That Met QC Criteria: June 22, 2020
• First Posted (ACTUAL): June 24, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 30, 2020
• Last Update Submitted That Met QC Criteria: June 27, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Hormone Antagonists; Aromatase Inhibitors; Steroid Synthesis Inhibitors; Estrogen Antagonists; Anastrozole
• Other Study ID Numbers: TG1915ANA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No