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

NCT ID: NCT00992238

Last Updated: 2023-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Flavoxate Hydrochloride Tablets, 100mg

Group Type EXPERIMENTAL

Flavoxate Hydrochloride Tablets, 100mg

Intervention Type DRUG

Urispas® Tablets, 100mg

Group Type ACTIVE_COMPARATOR

Urispas® Tablets, 100mg

Intervention Type DRUG

Interventions

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Flavoxate Hydrochloride Tablets, 100mg

Intervention Type DRUG

Urispas® Tablets, 100mg

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Padagis LLC

INDUSTRY

Sponsor Role lead

Principal Investigators

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Carlson, Pharm.D.

Role: PRINCIPAL_INVESTIGATOR

PRACS Institute, Ltd.

Locations

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PRACS Institute, Ltd

Fargo, North Dakota, United States

Site Status

Countries

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United States

Other Identifiers

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R03155

Identifier Type: -

Identifier Source: org_study_id

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