Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-02-25 @ 7:27 PM
Study NCT ID:
NCT01853956
Status:
COMPLETED
Last Update Posted:
2017-06-14
First Post:
2012-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence Trial of Alprazolam 0.25 mg Tablets
Sponsor:
GlaxoSmithKline
Organization:
Study Overview
Official Title:
Open,Two-period, Two-treatment, Two-sequence, Cross-over, Randomized Trial of Single Doses of Two Oral Preparations With 0.25 mg of Alprazolam (Zamoprax® GlaxoSmithKline México, S.A. de C.V. vs. Tafil® 0.25mg, Pharmacia &Upjohn, S.A. de C.V.) in Fasting Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2017-06
Last Known Status:
None
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:
The objective of this study was to confirm if two formulations of alprazolam (tablets) are bioequivalent.
Test product was Zamoprax® 0.25 mg (GlaxoSmithKline) and reference product Tafil® 0.25 mg (Pharmacia \& Upjohn). One tablet was the single dosage.
The study was prospective, open-label, randomized, crossover, single dose, with 02 treatments, 02 sequences and 02 periods, under fasting conditions.
The population was composed of 28 healthy volunteers, both genders, adults between 18-50 years.
The comparative bioavailability of the two formulations was evaluated based in statistical comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations in blood.
Test product was Zamoprax® 0.25 mg (GlaxoSmithKline) and reference product Tafil® 0.25 mg (Pharmacia \& Upjohn). One tablet was the single dosage.
The study was prospective, open-label, randomized, crossover, single dose, with 02 treatments, 02 sequences and 02 periods, under fasting conditions.
The population was composed of 28 healthy volunteers, both genders, adults between 18-50 years.
The comparative bioavailability of the two formulations was evaluated based in statistical comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations in blood.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: