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

NCT01227811 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2010-10-25

No results posted yet for this study

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.

Conditions

  • Bioequivalency

Interventions

DRUG

Darifenacin

Single oral dose Darisec(R) 15.0 mg

DRUG

Darifenacin

Single oral dose Enablex(R) 15 mg

Sponsors & Collaborators

  • Laboratorio Elea Phoenix S.A.

    collaborator INDUSTRY

  • Center for Clinical Pharmacology Research Bdbeq S.A.

    lead OTHER

Principal Investigators

  • Francisco E. Estevez-Carrizo, MD · Univerisity of Montevideo. Biomedical Science Center.Prudencio de Pena 2440, 11600 Montevideo. Uruguay

  • Susana Parrillo, M.D. · Center for Clinical Pharmacology Research Bdbeq S.A., Br. Artigas 1632. c.p. 11600 Montevideo. Uruguay.

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2010-12-31
Completion
2011-03-31

Countries

  • Uruguay

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01227811 on ClinicalTrials.gov