A Relative Bioavailability Study of 100 mg Flavoxate Hydr... | NCT00992238

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

NCT00992238

Sponsor

Padagis LLC

Status

Completed

Last Update Posted

Jul 10, 2023Actual

Enrollment

Phase

Phase 1

Conditions

Healthy

Interventions

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

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Oct 7, 2009

First Submission Date that Met QC Criteria

Oct 8, 2009

First Posted Date

Oct 9, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 7, 2023

Last Update Posted Date

Jul 10, 2023Actual

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Flavoxate Hydrochloride Tablets, 100mg	Experimental		Drug: Flavoxate Hydrochloride Tablets, 100mg
Urispas® Tablets, 100mg	Active Comparator		Drug: Urispas® Tablets, 100mg

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Flavoxate Hydrochloride Tablets, 100mg	Drug		Flavoxate Hydrochloride Tablets, 100mg
Urispas® Tablets, 100mg

Measure	Description	Time Frame
Bioequivalence according to US FDA guidelines

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Carlson, Pharm.D.	PRACS Institute, Ltd.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
PRACS Institute, Ltd		Fargo	North Dakota	58104	United States

Intervention Browse Module

MeSH Terms

ID	Term
D005422	Flavoxate

Ancestor Terms

ID	Term
D047309	Flavones
D005419	Flavonoids
D002867	Chromones
D001578	Benzopyrans
D011714

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Browse Branches

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