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

This study has been completed.
Sponsor:
Information provided by:
Paddock Laboratories, Inc.
ClinicalTrials.gov Identifier:
NCT00992238
First received: October 7, 2009
Last updated: September 24, 2013
Last verified: October 2009
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: Flavoxate Hydrochloride Tablets, 100mg
Drug: Urispas® Tablets, 100mg
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Relative Bioavailability Study of 100 mg Flavoxate Hydrochloride Tablets Under Fasting Conditions

Resource links provided by NLM:


Further study details as provided by Paddock Laboratories, Inc.:

Primary Outcome Measures:
  • Bioequivalence according to US FDA guidelines [ Designated as safety issue: No ]

Estimated Enrollment: 48
Arms Assigned Interventions
Experimental: Flavoxate Hydrochloride Tablets, 100mg Drug: Flavoxate Hydrochloride Tablets, 100mg
Active Comparator: Urispas® Tablets, 100mg Drug: Urispas® Tablets, 100mg

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00992238

Locations
United States, North Dakota
PRACS Institute, Ltd
Fargo, North Dakota, United States, 58104
Sponsors and Collaborators
Paddock Laboratories, Inc.
Investigators
Principal Investigator: Carlson, Pharm.D. PRACS Institute, Ltd.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00992238     History of Changes
Other Study ID Numbers: R03155
Study First Received: October 7, 2009
Last Updated: September 24, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Flavoxate
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014