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Bioequivalence Study for Terbinafine 250 mg

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ClinicalTrials.gov Identifier: NCT01772212
Recruitment Status : Completed
First Posted : January 21, 2013
Last Update Posted : June 22, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment Phase
Mycoses Drug: Terbinafine 250 mg Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Bioequivalence Study Between Two Medications for the Oral Administration of Terbinafine 250 mg in Oral Solids in Healthy Volunteers
Actual Study Start Date : February 24, 2011
Primary Completion Date : March 15, 2011
Study Completion Date : March 15, 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 ]
    pharmacokinetics

  2. 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 ]
    pharmacokinetics


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01772212


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

Additional Information:
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01772212     History of Changes
Other Study ID Numbers: 116827
First Posted: January 21, 2013    Key Record Dates
Last Update Posted: June 22, 2017
Last Verified: June 2017

Keywords provided by GlaxoSmithKline:
Mexico
terbinafine
mycoses
pharmacokinetics

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