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

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.

Completed

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Key information

Conditions

Healthy

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PRACS Institute, Ltd

Fargo, North Dakota, 58104, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Flavoxate Hydrochloride Tablets, 100mg

Drug

Urispas® Tablets, 100mg

Drug

Primary outcomes

Bioequivalence according to US FDA guidelines

Sponsors and collaborators

Lead sponsor

Padagis LLC

Industry

Registry information

Important dates

First posted: Oct 9, 2009
Registry last updated: Jul 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed