NCT00833586 is a Phase 1 clinical trial of Terbinafine HCl 250mg tablets in Healthy, sponsored by Teva Pharmaceuticals USA.

Who is sponsoring NCT00833586?

NCT00833586 is sponsored by Teva Pharmaceuticals USA.

What drugs are being tested in NCT00833586?

Interventions in NCT00833586: Terbinafine HCl 250mg tablets, Lamisil® 250 mg Tablets.

Is NCT00833586 still recruiting?

NCT00833586 is currently completed. Last updated 15 August 2024.

Are results published for NCT00833586?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-08-15 · How we verify

NCT00833586

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

The Relative Bioavailability of Two Terbinafine HCl 250 mg Tablet Formulations Under Fasting Conditions

Completed Phase 1 Results posted Last updated 15 August 2024

What this trial tests

Phase 1 trial testing Terbinafine HCl 250mg tablets in Healthy in 28 participants. Completed in 1 January 2002.

Timeline

1 January 2002

Primary endpoint
1 January 2002

1 January 2002

Quick facts

Lead sponsor	Teva Pharmaceuticals USA
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	other
Enrollment	28
Start date	1 January 2002
Primary completion	1 January 2002
Estimated completion	1 January 2002
Sites	1 location across United States

Drugs / interventions tested

Terbinafine HCl 250mg tablets — full drug profile →
Lamisil® 250 mg Tablets — full drug profile →

Conditions studied

Healthy — all drugs for Healthy →

Sponsor

Teva Pharmaceuticals USA — full company profile →

Who can join

18 and older, any sex, with Healthy. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Cmax - Maximum Observed Concentration - Terbinafine in Plasma
Time frame: Blood samples collected over 144 hour period
Bioequivalence based on Cmax
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Terbinafine in Plasma
Time frame: Blood samples collected over 144 hour period
Bioequivalence based on AUC0-inf
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Terbinafine in Plasma
Time frame: Blood samples collected over 144 hour period
Bioequivalence based on AUC0-t

Sponsor's own description

The purpose of this study is to evaluate the relative bioavailability of the test formulation of terbinafine tablets with an already marketed reference formulation Lamisil® (Novartis Pharmaceuticals), under fasted conditions in healthy, non-tobacco using male and female adult subjects.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

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Other Teva Pharmaceuticals USA trials

Trials by the same sponsor.

NCT06742957 — Study Comparing Tapinarof Cream 1% To VTAMA ® (Tapinarof Cream 1%) In the Treatment of Plaque Psoriasis · Phase 3 · completed
NCT05617820 — Study Comparing Estradiol Vaginal Inserts 4mcg To IMVEXXY ® (Estradiol Vaginal Inerts 4 mcg) In The Treatment Of Dyspare · Phase 3 · completed
NCT05550337 — Study Comparing Trifarotene Cream, 0.005% To AKLIEF ® (Trifarotene 0.005% Cream) In The Treatment Of Acne Vulgaris · Phase 3 · completed
NCT04976192 — Study to Compare Efficacy and Safety of TEV-45779 With XOLAIR (Omalizumab) in Adults With Chronic Idiopathic Urticaria · Phase 3 · completed
NCT04729621 — A Study to Test if TVB-009P is Effective in Relieving Postmenopausal Osteoporosis · Phase 3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00833586 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Teva Pharmaceuticals USA
Last refreshed: 15 August 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00833586.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing