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

NCT04445922 | Unknown Phase 1 DMC

• 1 other identifier: TG1915ANA
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

test-anastrozole tablet

EXPERIMENTAL

1 mg anastrozole was produced and provided by Salutas Pharma GmbH

Drug: test-anastrozole tablet (Salutas Pharma GmbH)

reference-anastrozole tablet

EXPERIMENTAL

1 mg anastrozole was produced by AstraZeneca Pharmaceuticals LP.

Drug: reference-anastrozole tablet

Interventions

test-anastrozole tablet (Salutas Pharma GmbH) 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

test-anastrozole tablet

reference-anastrozole tablet 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

Also known as: Arimidex

reference-anastrozole tablet

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• The Affiliated Hospital of Qingdao University: lead

Study Sites (1)

Phase I Clinical Research Center

Qingdao, Shandong, 266003, China

Location

MeSH Terms

Interventions

Anastrozole

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Yu Cao, doctor

  the study director of phase I clinical research center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu Cao, doctor

CONTACT

86 18661809090; caoyu1767@126.com

Ye Tao, master

CONTACT

86 17853287551; taoye165298765@163.com

Study Design

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

Study Record Dates

• First Submitted: June 22, 2020
• First Posted: June 24, 2020
• Study Start: July 4, 2020
• Primary Completion: August 3, 2020
• Study Completion: October 30, 2020
• Last Updated: June 30, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)