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Bioequivalency Study of Terbinafine Tablets Under Fasting Conditions

2014-07-24 14:19:06 | BioPortfolio

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.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Onychomycosis

Intervention

Terbinafine

Location

Gateway Medical Research, Inc.
St. Charles
Missouri
United States
63301

Status

Completed

Source

Roxane Laboratories

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:19:06-0400

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Medical and Biotech [MESH] Definitions

A fungal infection of the nail plate, usually caused by a DERMATOPHYTES; YEASTS; or nondermatophyte MOLDS.

Separation of nail plate from the underlying nail bed. It can be a sign of skin disease, infection (such as ONYCHOMYCOSIS) or tissue injury.

OPPORTUNISTIC INFECTIONS with the soil fungus FUSARIUM. Typically the infection is limited to the nail plate (ONYCHOMYCOSIS). The infection can however become systemic especially in an IMMUNOCOMPROMISED HOST (e.g., NEUTROPENIA) and results in cutaneous and subcutaneous lesions, fever, KERATITIS, and pulmonary infections.

A mitosporic fungal genus commonly found in soil. It includes both saprophytes and animal pathogens. Scopulariopsis brevicaulis and related species may convert ARSENIC to volatile and toxic arsine. ONYCHOMYCOSIS and rarely BRAIN ABSCESS; MYCETOMA, and disseminated infections mainly in the IMMUNOCOMPROMISED HOSTS are associated with Scopulariopsis.

A general term describing various dermatophytoses. Specific types include TINEA CAPITIS (ringworm of the scalp), TINEA FAVOSA (of scalp and skin), TINEA PEDIS (athlete's foot), and tinea unguium (see ONYCHOMYCOSIS, ringworm of the nails). (Dorland, 27th ed)

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