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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
Intervention Model: Crossover Assignment
Masking: None (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

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   (Adult, Senior)
Sexes Eligible for Study:   All
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

ClinicalTrials.gov Identifier: NCT00992238     History of Changes
Other Study ID Numbers: R03155
Study First Received: October 7, 2009
Last Updated: September 24, 2013

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

ClinicalTrials.gov processed this record on September 19, 2017