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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Urological Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 16, 2014