Single Dose Two-periods Crossover Bioequivalence Study of Darifenacin Tablets in Healthy Volunteers.
NCT ID: NCT01227811
Last Updated: 2010-10-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
24 participants
INTERVENTIONAL
2010-11-30
2011-03-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
NONE
Study Groups
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Enablex(R) 15 mg , single dose
Darifenacin
Single oral dose Enablex(R) 15 mg
Darifenacin 15 mg tablets, single dose
Darifenacin
Single oral dose Darisec(R) 15.0 mg
Interventions
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Darifenacin
Single oral dose Darisec(R) 15.0 mg
Darifenacin
Single oral dose Enablex(R) 15 mg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
50 Years
ALL
Yes
Sponsors
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Laboratorio Elea Phoenix S.A.
INDUSTRY
Center for Clinical Pharmacology Research Bdbeq S.A.
OTHER
Responsible Party
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Center for Clinical Pharmacology Research Bdbeq S.A.
Principal Investigators
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Francisco E. Estevez-Carrizo, MD
Role: STUDY_DIRECTOR
Univerisity of Montevideo. Biomedical Science Center.Prudencio de Pena 2440, 11600 Montevideo. Uruguay
Susana Parrillo, M.D.
Role: PRINCIPAL_INVESTIGATOR
Center for Clinical Pharmacology Research Bdbeq S.A., Br. Artigas 1632. c.p. 11600 Montevideo. Uruguay.
Locations
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Center for Clinical Pharmacology Research Bdbeq S.A.; Hospital Italiano de Montevideo..
Montevideo, Montevideo Department, Uruguay
Countries
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Central Contacts
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Facility Contacts
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References
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Skerjanec A. The clinical pharmacokinetics of darifenacin. Clin Pharmacokinet. 2006;45(4):325-50. doi: 10.2165/00003088-200645040-00001.
Other Identifiers
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BDBEQ_DFNLP/ELEA_011
Identifier Type: -
Identifier Source: org_study_id