A Phase 1 interventional study of test-anastrozole tablet (Salutas Pharma GmbH) and reference-anastrozole tablet in Healthy Volunteers, sponsored by The Affiliated Hospital of Qingdao University. Status unknown at 1 site in China. Open to female participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-30.
Sponsored by The Affiliated Hospital of Qingdao University · Phase 1, Interventional, and Treatment
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.
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.
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1 mg anastrozole was produced and provided by Salutas Pharma GmbH
Drug: test-anastrozole tablet (Salutas Pharma GmbH)
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
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
Also known as: Arimidex
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%.
Time frame: 60 days
Plan to share: No
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The Affiliated Hospital of Qingdao University