NCT00864071

A Relative Bioavailability Study of Griseofulvin 125 mg/5 mL Suspension Under Fasting Conditions

A Two-Way Crossover, Open-Label, Single-Dose, Fed, Bioequivalence Study Of Griseofulvin 125 mg/5 mL Suspension Versus Grifulvin V® 125 mg/5 mL Suspension In Normal, Healthy, Non-Smoking Male And Female Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Actavis Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

To compare the rate and extent of absorption of griseofulvin from a test formulation of Griseofulvin 125 mg/5 mL Suspension versus the reference Grifulvin V® 125 mg/5 mL Suspension under fasting conditions.

Detailed description

Study Type: Interventional Study Design: A randomized, two-way crossover, open-label, single-dose, fasting design. Official Title: A TWO-WAY CROSSOVER, OPEN-LABEL, SINGLE-DOSE, FED, BIOEQUIVALENCE STUDY OF GRISEOFULVIN 125 mg/5 mL SUSPENSION VERSUS GRIFULVIN V® 125 mg/5 mL SUSPENSION IN NORMAL, HEALTHY, NON-SMOKING MALE AND FEMALE SUBJECTS Further study details as provided by Actavis Elizabeth LLC: Primary Outcome Measures: Rate and Extend of Absorption

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Griseofulvin 125 mg/5 mL Suspension, single dose	A: Experimental Subjects received Alpharma formulated products under fasting conditions
DRUG	Grifulvin V® 125 mg/5 mL Suspension, single dose	B: Active comparator Subjects received Ortho Neutrogena formulated products under fasting conditions

Timeline

• Start date: 2005-11-01
• Primary completion: 2005-11-01
• Completion: 2005-11-01
• First posted: 2009-03-18
• Last updated: 2010-08-16

Locations

1 site across 1 country: Canada