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

Padagis

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Urispas® Tablets, 100mg; Drug: Flavoxate Hydrochloride Tablets, 100mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00992238

R03155

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

Flavoxate Hydrochloride Tablets, 100mg

Experimental group

Treatment:

Drug: Flavoxate Hydrochloride Tablets, 100mg

Urispas® Tablets, 100mg

Active Comparator group

Treatment:

Drug: Urispas® Tablets, 100mg