Single Dose Bioequivalence Study of Darifenacin Tablets 7.5 mg in Fed Healthy Volunteers.

Bioequivalency Clinical Trial

Official title: Comparative Bioavailability of Darifenacin Extended Release Oral Formulation [Darisec(R)7.5 mg vs. Enablex(R)7.5 mg]: Single-dose, Postprandial State, Randomized, Two-sequence, Two-period, Crossover Study in Healthy Volunteers.

Status Unknown status

Clinical Trial Summary

The proposed study was designed as a randomized two-sequence, two period crossover trial to assess the bioequivalence, pharmacokinetic profiling and safety of a brand generic formulation of darifenacin [Darisec(R) 7.5 mg] vs. the innovator [Enablex(R)7.5 mg]in healthy volunteers in postprandial state.

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. A bioequivalence study will be performed to validate pharmaceutical development before introducing the product in the market.

The purpose in this study is to evaluate the relative bioavailability, pharmacokinetic profiling and safety of a brand generic formulation of darifenacin [Darisec(R) 7.5 mg] vs. the innovator [Enablex(R) 7.5 mg]in 24 healthy uruguayan volunteers after a high fat breakfast of 1000 calories (50% fat, 35% carbohydrates, and 15% proteins)to establish their average bioequivalence.

The bioequivalence will be evaluated using:

• The Area Under the Curve (AUC),

• The peak plasma concentration (Cmax).

The pharmacokinetic characteristics of the drug formulations will be described calculating:

• The time to peak concentration (Tmax)

• The elimination constant (Ke)

• The elimination half-life (t1/2e)

• The systemic clearance (Cls)

Safety will be evaluated recording:

• Reported adverse events

• Vital signs (blood pressure, heart rate, body temperature)

• 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 requirements:

• Mean AUCt/AUCr and 90% confidence interval within 0.80-1.25

• Mean Cmaxt/Cmaxr and 90% confidence interval within 0.80-1.25

Pharmacokinetic profiling will be evaluated by describing the pharmacokinetic characteristics of both drug in adequate two-way tables.

Safety will be evaluated comparing incidence of adverse events/adverse effects for both products. ;

Related Conditions & MeSH terms

• Bioequivalency

• NCT number: NCT01229280
• 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: December 2010
• Completion date: February 2011