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

Information source: Paddock Laboratories, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Flavoxate Hydrochloride Tablets, 100mg (Drug); Urispas® Tablets, 100mg (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Paddock Laboratories, Inc.

Official(s) and/or principal investigator(s):
Carlson, Pharm.D., Principal Investigator, Affiliation: PRACS Institute, Ltd.

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Bioequivalence according to US FDA guidelines

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

PRACS Institute, Ltd, Fargo, North Dakota 58104, United States
Additional Information


Last updated: September 24, 2013

Page last updated: August 23, 2015

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