Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2025-12-31 @ 3:00 PM
Study NCT ID:
NCT04438733
Status:
UNKNOWN
Last Update Posted:
2020-06-30
First Post:
2020-06-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence of Oral Formulations of Anastrozole in Healthy Chinese Volunteers Under Fasted Condition
Sponsor:
The Affiliated Hospital of Qingdao University
Organization:
Study Overview
Official Title:
Bioequivalence of Oral Formulations of Anastrozole in Healthy Chinese Volunteers Under Fasted Condition: A Open-label, Randomized,Single-dose,Two-period, Two-group, Crossover Study
Status:
UNKNOWN
Status Verified Date:
2020-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
An open-label, randomized, two-period, two-group, crossover study was conducted in 26 healthy Chinese volunteers under fasted 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 volunteers were enrolled and completed the study, after oral administration of a single dose of 1.0-mg test and reference formulations of anastrozole. Blood samples (3 mL) for pharmacokinetic analysis were collected predose and 20min, 40min, 1, 1h20min, 1h40min, 2, 2h20min, 2h40min, 3, 3.5, 4, 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: