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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00992238

Enrollment

Registered

2009-10-09

Start date

Unknown

Completion date

Unknown

Last updated

2023-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

DRUGFlavoxate Hydrochloride Tablets, 100mg

DRUGUrispas® Tablets, 100mg

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Bioequivalence according to US FDA guidelines	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026