Bioequivalence Study for Terbinafine 250 mg

NCT01772212 | Completed Phase 1

• 1 other identifier: 116827
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Mycoses

Keywords

Mexico; terbinafine; mycoses; pharmacokinetics

Outcome Measures

Primary Outcomes (2)

• Peak Plasma Concentration (CMAX) of drug terbinafine

  pharmacokinetics

  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

• Area under the plasma concentration versus time curve (AUC) of drug terbinafine

  pharmacokinetics

  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

Study Arms (2)

A(test)/B(reference)

EXPERIMENTAL

Initial administration of test and crossover to reference

Drug: Terbinafine 250 mg

B(reference)/A(test)

EXPERIMENTAL

Initial administration of reference and crossover to test

Drug: Terbinafine 250 mg

Interventions

Terbinafine 250 mg DRUG

Test product

Also known as: Xilatril® is a registered trademark of Laboratorios Dermatológicos Darier

A(test)/B(reference); B(reference)/A(test)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Related Links

• Results for study 116827 can be found on the GSK Clinical Study Register.

MeSH Terms

Conditions

Mycoses

Interventions

Terbinafine

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2013
• First Posted: January 21, 2013
• Study Start: February 24, 2011
• Primary Completion: March 15, 2011
• Study Completion: March 15, 2011
• Last Updated: June 22, 2017

Record last verified: 2017-06