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

NCT01227811 | Unknown Phase 1

• 1 other identifier: BDBEQ_DFNLP/ELEA_011
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Darifenacin; Bioequivalence; Healthy volunteers; Postprandial

Outcome Measures

Primary Outcomes (2)

• Extent of Absorption.

  Extent of absorption will be measured using the area under plasma concentrations of darifenacin vs. time from time 0 to the last sample point (AUC0-t) and from time 0 to infinity (AUC0-inf).

  72 hours

• Rate of Absorption

  Rate of abosrption will be measured using the peak concentration of darifenacin (Cmax).

  72

Secondary Outcomes (3)

• Time to peak concentration (tmax)

  72 hours

• Absorption Rate Constant(Ka)

  72 hours

• Elimination Rate Constant (Ke)

  72

Study Arms (2)

Enablex(R) 15 mg , single dose

ACTIVE COMPARATOR

Drug: Darifenacin

Darifenacin 15 mg tablets, single dose

EXPERIMENTAL

Drug: Darifenacin

Interventions

Darifenacin DRUG

Single oral dose Darisec(R) 15.0 mg

Also known as: Muscarinic Antagonists, Cholinergic Antagonists, Cholinergic Agents, Enablex, Darisec

Darifenacin 15 mg tablets, single dose

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male or female subjects 18 to 50 years of age (inclusive)
• In good health, as determined by lack of clinically significant abnormalities at screening as judged by the physician.
• Female subjects are required to use a medically accepted method of hormonal contraception or abstinence throughout the entire study period and for one week after the study is completed.
• Body mass index within the range of 18.5 and 29.9 kg/m2 and weight at least 45 kg.

You may not qualify if:

• Known hypersensitivity or severe adverse event to darifenacin or similar drugs.
• Urinary retention, narrow-angle glucoma, myasthenia gravis, severe hepatic impairment, severe ulcerative colitis, toxic megacolon.
• Symptomatic hiatus hernia, erosive or symptomatic gastroesophageal reflux disease/heartburn (\>2 days in a week), severe constipation, gastrointestinal obstructive disorder, and gastric retention.
• Clinically significant cardiac abnormalities, fainting, low blood pressure upon standing, irregular heartbeats.
• Acute or chronic bronchospastic disease (including asthma and Chronic Obstructive Pulmonary Disease).
• Clinically significant drug allergy or history of atopic allergy (asthma, urticaria, eczematous dermatitis).
• Smokers of more than 5 cigarettes a week.
• Regular use of any drugs known to induce or inhibit hepatic drug metabolism (particularly those that affect CYP2D6) within 30 days prior to each study drug administration.
• Any surgical or medical condition wich might significantly alter the absorption, distribution, metabolism or excretion of drugs which may jeopardize participation in the study.
• Immunodeficiency diseases, including a positive HIV (Elisa or Western blot) test result.
• Positive hepatitis B Surface antigen (HBsAg) or Hepatitis C test result.
• Drug or alcohol abuse within the 6 months prior to dosing.
• Use of prescription drugs within 1 month prior to dosing, or over-the-counter medication (vitamine, herbal supplements, dietary supplements) within 2 weeks prior to dosing. Paracetamol and ibuprofen are acceptable.
• Participation in any clinical investigation within 4 weeks prior to dosing.
• Donation or loss of 400 ml or more of blood within 2 months prior to dosing.

Sponsors & Collaborators

• Center for Clinical Pharmacology Research Bdbeq S.A.: lead
• Laboratorio Elea Phoenix S.A.: collaborator

Study Sites (1)

Center for Clinical Pharmacology Research Bdbeq S.A.; Hospital Italiano de Montevideo..

Montevideo, Montevideo Department, 11600, Uruguay

Location

Related Publications (1)

• Skerjanec A. The clinical pharmacokinetics of darifenacin. Clin Pharmacokinet. 2006;45(4):325-50. doi: 10.2165/00003088-200645040-00001.

  PMID: 16584282 BACKGROUND

MeSH Terms

Interventions

darifenacin; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents

Intervention Hierarchy (Ancestors)

Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs

Study Officials

• Francisco E. Estevez-Carrizo, MD

  Univerisity of Montevideo. Biomedical Science Center.Prudencio de Pena 2440, 11600 Montevideo. Uruguay

  STUDY DIRECTOR

• Susana Parrillo, M.D.

  Center for Clinical Pharmacology Research Bdbeq S.A., Br. Artigas 1632. c.p. 11600 Montevideo. Uruguay.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Federico Santoro, MD

CONTACT

+541143794300; santorof@elea.com

Joanna Steimberg, MBA

CONTACT

+541143794330; steimbej@elea.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 18, 2010
• First Posted: October 25, 2010
• Study Start: November 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: March 1, 2011
• Last Updated: October 25, 2010

Record last verified: 2010-10

Locations

UR (1)