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

Bioequivalency Clinical Trial

Official title: 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 status

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Bioequivalency

• NCT number: NCT01227811
• Study type: Interventional
• Source: Center for Clinical Pharmacology Research Bdbeq S.A.
• Contact: Federico Santoro, MD
• Phone: +541143794300
• Email: santorof@elea.com
• Status: Unknown status
• Phase: Phase 1
• Start date: November 2010
• Completion date: March 2011