A Relative Bioavailability Study of 100 mg Flavoxate Hydrochloride Tablets Under Fasting Conditions
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Drug: Urispas® Tablets, 100mg
- Registration Number
- NCT00992238
- Lead Sponsor
- Padagis LLC
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Urispas® Tablets, 100mg Urispas® Tablets, 100mg - Flavoxate Hydrochloride Tablets, 100mg Flavoxate Hydrochloride Tablets, 100mg -
- Primary Outcome Measures
Name Time Method Bioequivalence according to US FDA guidelines
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
PRACS Institute, Ltd
🇺🇸Fargo, North Dakota, United States