A Relative Bioavailability Study of 100 mg Flavoxate Hydrochloride Tablets Under Fasting Conditions

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Urispas® Tablets, 100mg; Drug: Flavoxate Hydrochloride Tablets, 100mg

• Registration Number: NCT00992238
• Lead Sponsor: Padagis LLC

Brief Summary

The purpose of this study is to compare the relative bioavailability of Flavoxate Hydrochloride tablets 100mg manufactured by Paddock Laboratories, Inc., with that of Urispas® tablets 100mg by SmithKline Beecham Pharmaceuticals under fasting conditions.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-10-07
• Study First Submitted QC: 2009-10-08
• Study First Posted: 2009-10-09
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-07
• Last Update Posted: 2023-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• Good health as determined by lack of clinically significant abnormalities in health assessment performed at screening

Exclusion Criteria

• Positive test results for HIV or Hepatitis B or C
• History of allergy or sensitivity to Flavoxate hydrochloride or related drugs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Urispas® Tablets, 100mg	Urispas® Tablets, 100mg	-
Flavoxate Hydrochloride Tablets, 100mg	Flavoxate Hydrochloride Tablets, 100mg	-

Primary Outcome Measures

Name	Time	Method
Bioequivalence according to US FDA guidelines

Trial Locations

Locations (1)

PRACS Institute, Ltd; 🇺🇸 Fargo, North Dakota, United States