NCT01227811

Single Dose Two-periods Crossover Bioequivalence Study of Darifenacin Tablets in Healthy Volunteers.

Single Dose, Two-period, Crossover, Fed Bioequivalence Study of Darifenacin Extended Release Oral Formulation (Darisec(R) 15 mg) vs. Enablex(R) 15 mg in Healthy Volunteers.

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Center for Clinical Pharmacology Research Bdbeq S.A. · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The present study was designed to assess the bioequivalence and pharmacokinetic profiling of a brand generic formulation of darifenacin \[Darisec(R)\]vs. the innovator \[Enablex(R)\]in healthy volunteers after a high fat breakfast. The bioequivalence will be evaluated using: * the Area Under the Curve (AUC) and, * the peak plasma concentration (Cmax). Safety will be evaluated recording: * vital signs * adverse events, * laboratory analysis. * EKG and chest XRays. Bioequivalence will be claimed if the drugs comply with local regulatory requirement, eg.: * mean AUCt/AUCr and 90% confidence interval within 0.80-1.25 * mean Cmaxt/Cmaxr and 90% confidence interval within 0.80-1.25.

Detailed description

Darifenacin is a muscarinic receptor antagonist drug used to treat overactive bladder. There is a new formulation of darifenacin extended release developed by an argentinian pharmaceutical company and, according to regional regulations, a bioequivalence study should be performed to put it in the market. The purpose of this study is to evaluate the relative bioavailability and pharmacokinetic profiling of a brand generic formulation of darifenacin \[Darisec(R) 15 mg\] vs. the innovator \[Enablex(R) 15 mg\] in 24 healthy uruguayan volunteers after a high fat breakfast of 1000 calories (50% fat, 35% carbohydrates (sugar, flour, etc.) and 15\& proteins) to establish their average bioequivalence. The bioequivalence will be evaluated using outcome measures that will be described later. The pharmacokinetic characteristics of the drugs will be described calculating: * the time to Cmax (Tmax) * the elimination constant (Ke), * the elimination half-life (t1/2e)and, * the systemic clearance (Cls. Safety will be evaluated recording: * vital signs (blood pressure, heart rate, body temperature) * adverse events, * laboratory analysis (hemogram, hepatic enzymes, creatinine, sugar in blood,etc.). * EKG and chest XRays. Bioequivalence will be claimed if the drugs comply with local and FDA regulatory requirement, eg.: * mean AUCt/AUCr and 90% confidence interval within 0.80-1.25 * mean Cmaxt/Cmaxr and 90% confidence interval within 0.80-1.25. Safety will be evaluated comparing incidences of adverse events/adverse effects for both products.

Conditions

• Bioequivalency

Interventions

Type	Name	Description
DRUG	Darifenacin	Single oral dose Darisec(R) 15.0 mg
DRUG	Darifenacin	Single oral dose Enablex(R) 15 mg

Timeline

• Start date: 2010-11-01
• Primary completion: 2010-12-01
• Completion: 2011-03-01
• First posted: 2010-10-25
• Last updated: 2010-10-25

Locations

1 site across 1 country: Uruguay