Fasting Study of Terbinafine Hydrochloride Tablets 250 mg and Lamisil® Tablets 250 mg
Summary
The objective of this study was to investigate the bioequivalence of Mylan's terbinafine hydrochloride 250 mg tablets to Novartis' Lamisil® 250 mg tablets following a single, oral 250 mg (1 x 250 mg) dose administered under fasting conditions.
Study Design
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label
Conditions
Healthy
Intervention
Terbinafine Hydrochloride Tablets 250 mg, Lamisil® Tablets 250 mg
Location
PRACS Institute, Ltd.
Fargo
North Dakota
United States
58104
Status
Completed
Source
Mylan Pharmaceuticals
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00647647
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Tablets, Enteric-coated
Tablets coated with material that delays release of the medication until after they leave the stomach. (Dorland, 28th ed)
Lactose
A disaccharide of GLUCOSE and GALACTOSE in human and cow milk. It is used in pharmacy for tablets, in medicine as a nutrient, and in industry.
Tablets
Solid dosage forms, of varying weight, size, and shape, which may be molded or compressed, and which contain a medicinal substance in pure or diluted form. (Dorland, 28th ed)
Excipients
Usually inert substances added to a prescription in order to provide suitable consistency to the dosage form. These include binders, matrix, base or diluent in pills, tablets, creams, salves, etc.
Talc
Finely powdered native hydrous magnesium silicate. It is used as a dusting powder, either alone or with starch or boric acid, for medicinal and toilet preparations. It is also an excipient and filler for pills, tablets, and for dusting tablet molds. (From Merck Index, 11th ed)
Clinical Trials
Fed Study of Terbinafine Hydrochloride Tablets 250 mg and Lamisil® 250 mg
The objective of this study was to investigate the bioequivalence of Mylan's terbinafine hydrochloride tablets to Novartis' Lamisil® tablets following a single, oral 250 mg (1 x 250 mg) d...
Terbinafine HCl 250 mg Tablet Formulations Under Non-Fasting Conditions
The Purpose of this study os to evaluate the relative bioavailability of the test formulation of terbinafine tablets with an already marketed reference formulation Lamisil® (Novartis Phar...
Bioequivalency Study of Terbinafine Tablets Under Fed Conditions
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 fed cond...
Bioequivalency Study of Terbinafine Tablets Under Fasting Conditions
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...
Food Study of Quinapril Hydrochloride Tablets 40 mg and Accupril® Tablets 40 mg
The objective of this study was to investigate the bioequivalence of Mylan quinapril hydrochloride 40 mg tablets compared to Parke-Davis Accupril® 40 mg tablets following a single, oral 4...
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