Fexofenadine Hydrochloride 180 mg Tablets Under Fasting Conditions

Phase 1 Completed 60 enrolled Teva Pharmaceuticals USA

RandomizedCrossoverOpen-label

Summary

This study will compare the relative bioavailability (rate and extent of absorption) of 180 mg Fexofenadine Hydrochloride tablets manufactured for TEVA Pharmaceuticals Industries, Ltd. with that of 180 mg ALLEGRA® Tablets by Aventis Pharmaceuticals, Inc. following a single oral dose (1 x 180 mg tablet) in healthy adult volunteers under fasting conditions.

Timeline

Start: 2002-03
Primary completion: 2002-03
Completion: 2002-03

Outcome

Met primary endpoint

registry analysis (non-inferiority or equivalence test); Fexofenadine Hydrochloride vs Allegra®; Ratio of the T/R geometric mean x 100 87.96 (90% CI 80.15 to 96.53) NCT00835276 ↗

registry analysis (non-inferiority or equivalence test); Fexofenadine Hydrochloride vs Allegra®; Ratio of the T/R geometric mean x 100 91.47 (90% CI 85.15 to 98.26) NCT00835276 ↗

registry analysis (non-inferiority or equivalence test); Fexofenadine Hydrochloride vs Allegra®; Ratio of the T/R geometric mean x 100 91.47 (90% CI 85.32 to 98.07) NCT00835276 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fexofenadine	Unknown	180 mg	Oral

Indications

No indication recorded.