Single Dose Bioequivalence Study of Darifenacin Tablets 7.5 mg in Fed Healthy Volunteers.
NCT ID: NCT01229280
Last Updated: 2010-10-27
Study Results
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Basic Information
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UNKNOWN
PHASE1
24 participants
INTERVENTIONAL
2010-12-31
2011-02-28
Brief Summary
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Detailed Description
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The purpose in this study is to evaluate the relative bioavailability, 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 24 healthy uruguayan volunteers after a high fat breakfast of 1000 calories (50% fat, 35% carbohydrates, and 15% proteins)to establish their average bioequivalence.
The bioequivalence will be evaluated using:
* The Area Under the Curve (AUC),
* The peak plasma concentration (Cmax).
The pharmacokinetic characteristics of the drug formulations will be described calculating:
* The time to peak concentration (Tmax)
* The elimination constant (Ke)
* The elimination half-life (t1/2e)
* The systemic clearance (Cls)
Safety will be evaluated recording:
* Reported adverse events
* Vital signs (blood pressure, heart rate, body temperature)
* 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 requirements:
* Mean AUCt/AUCr and 90% confidence interval within 0.80-1.25
* Mean Cmaxt/Cmaxr and 90% confidence interval within 0.80-1.25
Pharmacokinetic profiling will be evaluated by describing the pharmacokinetic characteristics of both drug in adequate two-way tables.
Safety will be evaluated comparing incidence 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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Darisec(R) 7.5 mg
Darifenacin
Single dose 7.5 mg tablets of darifenacin
Enablex(R) 7.5 mg
Darifenacin
Single dose 7.5 mg tablets of Darifenacin
Interventions
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Darifenacin
Single dose 7.5 mg tablets of darifenacin
Darifenacin
Single dose 7.5 mg tablets of Darifenacin
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 glaucoma, 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 drug 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 which 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 results.
* 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 (vitamins, herbal supplements, dietary supplements)within 2 weeks prior to dosing. Paracetamol and ibuprofen are acceptable.
* Participation in any clinical investigation within 12 weeks prior to dosing.
* Donation or loss of 400 ml or more of blood within 8 weeks 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 (CCPR) Bdbeq S.A. Hospital Italiano.
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.
Croom KF, Keating GM. Darifenacin: in the treatment of overactive bladder. Drugs Aging. 2004;21(13):885-92; discussion 893-4. doi: 10.2165/00002512-200421130-00005.
Staskin DR. Overactive bladder in the elderly: a guide to pharmacological management. Drugs Aging. 2005;22(12):1013-28. doi: 10.2165/00002512-200522120-00003.
Kerbusch T, Wahlby U, Milligan PA, Karlsson MO. Population pharmacokinetic modelling of darifenacin and its hydroxylated metabolite using pooled data, incorporating saturable first-pass metabolism, CYP2D6 genotype and formulation-dependent bioavailability. Br J Clin Pharmacol. 2003 Dec;56(6):639-52. doi: 10.1046/j.1365-2125.2003.01967.x.
Dmochowski RR, Appell RA. Advancements in pharmacologic management of the overactive bladder. Urology. 2000 Dec 4;56(6 Suppl 1):41-9. doi: 10.1016/s0090-4295(00)01020-7.
Other Identifiers
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BDBEQ_DFNLP/ELEA_010
Identifier Type: -
Identifier Source: org_study_id