NCT00602342

Completed

Bioequivalency Study of Terbinafine Tablets Under Fasting Co...

Roxane Laboratories Source

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Other study identifiers

Sponsor study identifier

TERB-01

Study Type

interventional

Actual enrollment (reported)

30

Locations

1 country

Sites

1

Timeline

Study Start

March 2004

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

April 2004

Actual (reported)

Study Completion

April 2004

Actual (reported)

Brief Summary

The objective of this study was the bioequivalence of a Roxane Laboratories' terbinafine tablets, 250 mg, to Lamisil® Tablets, 250 mg (Novartis Pharmaceutical Corporation.) under fasting conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 30 participants
Study completion date: April 2004
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
March 2004
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
April 2004
Actual (reported)
Study Completion
April 2004
Actual (reported)
First Submitted
January 15, 2008
Actual (reported)
First Posted
January 28, 2008
Actual (reported)

Last Updated: January 23, 2018
Status Verified: January 2018
Last Update Submitted: January 19, 2018

Conditions

Onychomycosis

Outcome Measures

Primary Outcomes (1)

Bioequivalence
Baseline, Two period, Twenty-one day washout

Interventions

TerbinafineDrug

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 45 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

You may not qualify if:

Sponsors & Collaborators

Roxane Laboratories
Industrylead

Study Sites (1)

Gateway Medical Research, Inc.

Saint Charles, Missouri, 63301, United States

MeSH Terms

Conditions

Onychomycosis

Interventions

Terbinafine

Condition Hierarchy (Ancestors)

TineaDermatomycosesMycosesBacterial Infections and MycosesInfectionsSkin Diseases, InfectiousNail DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

NaphthalenesPolycyclic Aromatic Hydrocarbons

Study Officials

Steven Herrmann, MD
Cetero Research, San Antonio
PRINCIPAL INVESTIGATOR

Enrollment

30 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: CROSSOVER
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

January 15, 2008

First Posted

January 28, 2008

Study Start

March 2004

Date type not reported

This date has not been verified as actual or estimated.

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NCT01452490

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NCT01534689

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NCT01819051

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Not ApplicableCompleted

Positive test for HIV, Hepatitis B, or Hepatitis C.

Treatment with known enzyme altering drugs.

History of allergic or adverse response to terbinafine or any comparable or similar product.

Contact the study team to confirm eligibility.

Hydrocarbons, Aromatic

Hydrocarbons, Cyclic

Hydrocarbons

Organic Chemicals

Polycyclic Compounds

Primary Completion

April 2004

Actual (reported)

Study Completion

April 2004

Actual (reported)

Last Updated

January 23, 2018

Record last verified: 2018-01

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00602342
Data provider: ClinicalTrials.gov
Source updated: 2018-01-23
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:31:46 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations