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

NCT01229280 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2010-10-27

No results posted yet for this study

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.

Conditions

  • Bioequivalency

Interventions

DRUG

Darifenacin

Single dose 7.5 mg tablets of darifenacin

DRUG

Darifenacin

Single dose 7.5 mg tablets of Darifenacin

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
2010-12-31
Primary Completion
2011-01-31
Completion
2011-02-28

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 NCT01229280 on ClinicalTrials.gov