Bioequivalence Study of Terbinafine Hydrochloride Tablets, 250 mg of Dr. Reddy's Under Fed Conditions

NCT01286701 | Completed Phase 1 DMC

• 1 other identifier: 01362
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the rate and extent of absorption of terbinafine hydrochloride 250 mg tablets versus Lamisil® 250 mg tablets administered as 1 x 250 mg tablet under fed conditions.

Conditions

Healthy

Keywords

Bioequivalence; crossover; Terbinafine hydrochloride; fed

Outcome Measures

Primary Outcomes (1)

• Bioequivalence study based on Cmax parameter

  3 months

Study Arms (2)

Terbinafine Hydrochloride

EXPERIMENTAL

Terbinafine Hydrochloride Tablets, 250 mg of Dr.Reddy's Laboratories Limited

Drug: Terbinafine Hydrochloride Tablets, 250 mg

Lamisil® 250 mg Tablets

ACTIVE COMPARATOR

Lamisil® 250 mg Tablets of Novartis

Drug: Terbinafine Hydrochloride Tablets, 250 mg

Interventions

Terbinafine Hydrochloride Tablets, 250 mg DRUG

Terbinafine Hydrochloride Tablets, 250 mg of Dr. Reddy's Laboratories Limited.

Also known as: Lamisil® 250 mg Tablets

Lamisil® 250 mg Tablets; Terbinafine Hydrochloride

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects enrolled in this study will be members of the community at large. The recruitment advertisements may be done using different media (e.g. radio, newspaper, Anapharm Web site, Anapharm volunteers' data base).
• Subjects must meet all of the following criteria in order to be included in the study:
• Subjects will be females and/or males, smokers and/or non-smokers, 18 years of age and older.

You may not qualify if:

• Subjects to whom any of the following applies will be excluded from the study:
• Clinically significant illnesses within 4 weeks of the administration of study medication.
• Clinically significant surgery within 4 weeks prior to the administration of the study medication.
• Any clinically significant abnormality found during medical screening.
• Any reason which, in the opinion of the medical sub-investigator, would prevent the subject from participating in the study.
• Abnormal laboratory tests judged clinically significant.
• Positive urine drug screen at screening.
• Positive testing for hepatitis B, hepatitis C or HIV at screening.
• ECG abnormalities (clinically significant) or vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, or diastolic blood pressure lower than 50 or over 90 mm Hg; or heart rate less than 50 bpm) at screening.
• Subjects with BMI ≥ 30.0.
• History of significant alcohol abuse within six months of the screening visit or any indication of the regular use of more than two units of alcohol per day (1 Unit = 150 mL of wine or 360 mL of beer or 45 mL of alcohol 40%).
• History of drug abuse or use of illegal drugs: use of soft drugs (such as marijuana) within 3 months of the screening visit or hard drugs (such as cocaine, phencyclidine (PCP) and crack) within 1 year of the screening visit.
• Any food allergy, intolerance, restriction or special diet that, in the opinion of the medical sub-investigator, contraindicates the subjects participation in this study.
• History of allergic reactions to terbinafine hydrochloride or other related drugs (e.g.naftifine).
• Use of any drugs known to induce or inhibit hepatic drug metabolism (examples of inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, rifampin/rifabutin;examples of inhibitors: antidepressants, cimetidine, diltiazem, erythromycin,ketoconazole, MAO inhibitors, neuroleptics, verapamil, quinidine), use of an investigational drug or participation in an investigational study within 30 days prior to administration of the study medication.

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead

Study Sites (1)

Anapharm Inc.

Québec, GIV 2K8, Canada

Location

MeSH Terms

Conditions

Lecithin Cholesterol Acyltransferase Deficiency

Interventions

Terbinafine

Condition Hierarchy (Ancestors)

Hypoalphalipoproteinemias; Hypolipoproteinemias; Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Eric Bicrell

  Anapharm

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 26, 2011
• First Posted: January 31, 2011
• Study Start: January 1, 2002
• Primary Completion: February 1, 2002
• Study Completion: March 1, 2002
• Last Updated: January 11, 2012

Record last verified: 2011-01

Locations

CA (1)