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

This study has been completed.

Sponsor:

Information provided by:

Paddock Laboratories, Inc.

ClinicalTrials.gov Identifier:

NCT00992238

First received: October 7, 2009

Last updated: October 8, 2009

Last verified: October 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

October 7, 2009

Last Updated Date

October 8, 2009

Start Date ^ICMJE

Not Provided

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Bioequivalence according to US FDA guidelines [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00992238 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Healthy

Intervention ^ICMJE

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

Study Arm (s)

Experimental: Flavoxate Hydrochloride Tablets, 100mg
Intervention: Drug: Flavoxate Hydrochloride Tablets, 100mg
Active Comparator: Urispas® Tablets, 100mg
Intervention: Drug: Urispas® Tablets, 100mg

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00992238

Other Study ID Numbers ^ICMJE

R03155

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Paddock Laboratories, Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Carlson, Pharm.D.

PRACS Institute, Ltd.

Information Provided By

Paddock Laboratories, Inc.

Verification Date

October 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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