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

Information source: Center for Clinical Pharmacology Research Bdbeq S.A.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bioequivalency

Intervention: Darifenacin (Drug); Darifenacin (Drug)

Phase: Phase 1

Status: Not yet recruiting

Sponsored by: Center for Clinical Pharmacology Research Bdbeq S.A.

Official(s) and/or principal investigator(s):
Francisco E. Estevez-Carrizo, MD, Study Director, Affiliation: Univerisity of Montevideo. Biomedical Science Center.Prudencio de Pena 2440, 11600 Montevideo. Uruguay
Susana Parrillo, M.D., Principal Investigator, Affiliation: Center for Clinical Pharmacology Research Bdbeq S.A., Br. Artigas 1632. c.p. 11600 Montevideo. Uruguay.

Overall contact:
Federico Santoro, MD, Phone: +541143794300, Email: santorof@elea.com

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 Details

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.

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Primary outcome:

Extent of Absorption.

Rate of Absorption

Secondary outcome:

Time to peak concentration (tmax)

Absorption Rate Constant(Ka)

Elimination Rate Constant (Ke)

Detailed 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.

Eligibility

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

- significant illness within 2 weeks prior to dosing.

- Other protocol-defined inclusion/exclusion criteria may apply.

Locations and Contacts

Federico Santoro, MD, Phone: +541143794300, Email: santorof@elea.com

Center for Clinical Pharmacology Research Bdbeq S.A.; Hospital Italiano de Montevideo.., Montevideo 11600, Uruguay; Not yet recruiting
Susana Parrillo, MD, Phone: +59824876288, Ext: 201, Email: sparrillo@bdbeq.com.uy
Mónica Cedrés, Pharm. B., Phone: +59824876288, Ext: 202, Email: mcedres@bdbeq.com.uy
Additional Information

Related publications:

Skerjanec A. The clinical pharmacokinetics of darifenacin. Clin Pharmacokinet. 2006;45(4):325-50. Review.

Starting date: November 2010
Last updated: October 22, 2010

Page last updated: August 23, 2015

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