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

NCT00864071 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2010-08-16

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

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

Sponsors & Collaborators

  • Actavis Inc.

    lead INDUSTRY

Principal Investigators

  • Paul Y. Tam,, MD · Biovail Contract Research

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-11-30
Primary Completion
2005-11-30
Completion
2005-11-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00864071 on ClinicalTrials.gov