NCT00992238

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 7, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 9, 2009

Completed
Last Updated

July 10, 2023

Status Verified

July 1, 2023

First QC Date

October 7, 2009

Last Update Submit

July 7, 2023

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Bioequivalence according to US FDA guidelines

Study Arms (2)

Flavoxate Hydrochloride Tablets, 100mg

EXPERIMENTAL
Drug: Flavoxate Hydrochloride Tablets, 100mg

Urispas® Tablets, 100mg

ACTIVE COMPARATOR
Drug: Urispas® Tablets, 100mg

Interventions

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

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Good health as determined by lack of clinically significant abnormalities in health assessment performed at screening

You may not qualify if:

  • Positive test results for HIV or Hepatitis B or C
  • History of allergy or sensitivity to Flavoxate hydrochloride or related drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PRACS Institute, Ltd

Fargo, North Dakota, 58104, United States

Location

MeSH Terms

Interventions

Flavoxate

Intervention Hierarchy (Ancestors)

FlavonesFlavonoidsChromonesBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Carlson, Pharm.D.

    PRACS Institute, Ltd.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 7, 2009

First Posted

October 9, 2009

Last Updated

July 10, 2023

Record last verified: 2023-07

Locations

US(1)