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Ivermectin Solution Bioequivalence Study - With Food (Repeat)

NCT00921219 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2011-10-06

No results posted yet for this study

Summary

The purpose of this study was to compare the pharmacokinetic and bioavailability profile (rate and amount of absorption into the bloodstream) of a test formulation of Ivermectin solution 1 mg/ml with a marketed reference formulation of Ivermectin 3 mg tablets when taken after a standard meal. The study is designed in accordance with the EU Note for Guidance on the Investigation of Bioavailability and Bioequivalence 2001.

Conditions

  • Healthy

Interventions

DRUG

ivermectin

Each subject will receive single doses of (i) 22.5 ml ivermectin oral solution (22.5 mg) and (ii) 10 x 3 mg tablets of ivermectin (30 mg) in 2 separate dosing periods. Doses will be administered 20 minutes after a standard breakfast.

Sponsors & Collaborators

  • Johnson & Johnson Consumer and Personal Products Worldwide

    lead INDUSTRY

Principal Investigators

  • Jerry Cottrell · McNeil UK

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-09-30
Primary Completion
2005-11-30
Completion
2005-11-30

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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 NCT00921219 on ClinicalTrials.gov