Bioequivalence Study for Terbinafine 250 mg

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01772212
First received: January 17, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  Purpose

The objective of this study was to confirm if two formulations of terbinafine (tablets) are bioequivalent.

Test product was Xilatril® 250 mg (Laboratorios Dermatológicos Darier) and reference product Lamisil® 250 mg (Novartis). One tablet was the single dosage.

The study was prospective, open-label, randomized, crossover, single dose, with 02 treatments, 02 sequences and 02 periods, under fasting conditions.

The population was composed of 30 healthy volunteers, both genders, adults between 18-50 years.

The comparative bioavailability of the two formulations was evaluated based in statistical comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations in blood.


Condition Intervention Phase
Mycoses
Drug: Terbinafine 250 mg
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Bioequivalence Study Between Two Medications for the Oral Administration of Terbinafine 250 mg in Oral Solids in Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Peak Plasma Concentration (CMAX) of drug terbinafine [ Time Frame: 0.0, 0.33, 0.66, 1.0, 1.33, 1.66, 2.0, 2.33, 2.66, 3.0, 3.5, 4.0, 6.0, 8.0, 10.0, 12.0, and 24.0 hours post dose ] [ Designated as safety issue: No ]
    pharmacokinetics

  • Area under the plasma concentration versus time curve (AUC) of drug terbinafine [ Time Frame: 0.0, 0.33, 0.66, 1.0, 1.33, 1.66, 2.0, 2.33, 2.66, 3.0, 3.5, 4.0, 6.0, 8.0, 10.0, 12.0, and 24.0 hours post dose ] [ Designated as safety issue: No ]
    pharmacokinetics


Enrollment: 30
Study Start Date: February 2011
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A(test)/B(reference)
Initial administration of test and crossover to reference
Drug: Terbinafine 250 mg
Test product
Other Name: Xilatril® is a registered trademark of Laboratorios Dermatológicos Darier
Drug: Terbinafine 250 mg
Reference product
Other Name: Lamisil® is a registered trademark of Novartis
Experimental: B(reference)/A(test)
Initial administration of reference and crossover to test
Drug: Terbinafine 250 mg
Test product
Other Name: Xilatril® is a registered trademark of Laboratorios Dermatológicos Darier
Drug: Terbinafine 250 mg
Reference product
Other Name: Lamisil® is a registered trademark of Novartis

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Inclusion Criteria: Males 18-50 years. Healthy based on comprehensive medical history, lab tests, Chest x-ray, Electrocardiogram, negative tests for Hepatitis B and C, and HIV. Negative urine doping test. BMI 19-26.5 kg/m2. Lab test in normal range +/- 10%. Blood pressure 139-90/89-50, heart rate 100-55, respiratory rate 24-17, temperature 37.5-35 °C. Non-smoking at least for 10 hrs before study. Written informed consent. -

Exclusion Criteria:

Hypersensitivity to study medication or other related drug. History of cardiovascular, renal, hepatic, metabolic, gastrointestinal, neurologic, endocrine, hematopoietic, psychiatric or organic condition.

Requiring any drug interfering with minocycline pharmacokinetics. Exposed to inducers or inhibitors of hepatic enzymes. Intake of possible toxic drugs 30 days before study. Intake of any drug 14 days or 7 half-lives before study. Hospitalization or severe disease 60 days before study. Receiving investigational drug out of study center 30 days before study. Blood loss or blood donation =>450 ml 60 days before study. Recent history of drug abuse including alcohol. Intake of xanthine containing products 10 hrs before study. Intake of grapefruit juice or hot-spice 10 hrs before study.

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  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01772212

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01772212     History of Changes
Other Study ID Numbers: 116827
Study First Received: January 17, 2013
Last Updated: January 17, 2013
Health Authority: Mexico: Comision Federal para la Proteccion contra Riesgos Sanitarios (COFEPRIS)

Keywords provided by GlaxoSmithKline:
Mexico
terbinafine
mycoses
pharmacokinetics

Additional relevant MeSH terms:
Mycoses
Terbinafine
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 31, 2014