NCT00921154

CompletedPhase 1

Ivermectin Solution Bioequivalence Study - Fasted

Johnson & Johnson Consumer and Personal Products Worldwide Source

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

SCO2704

Study Type

interventional

Actual enrollment (reported)

24

Locations

1 country

Sites

1

Timeline

Study Start

March 2005

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

May 2005

Actual (reported)

Study Completion

September 2005

Actual (reported)

Brief 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 an overnight fast .The study is designed in accordance with the EU Note for Guidance on the Investigation of Bioavailability and Bioequivalence 2001.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 24 participants
Study completion date: September 2005
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
March 2005
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
May 2005
Actual (reported)
Study Completion
September 2005
Actual (reported)
First Submitted
June 15, 2009
Actual (reported)
First Posted
June 16, 2009
Actual (reported)

Last Updated: October 6, 2011
Status Verified: October 2011
Last Update Submitted: October 4, 2011

Conditions

Healthy

Keywords

therapeutic equivalencypharmacokineticsfastingHealthy Volunteers

Outcome Measures

Primary Outcomes (1)

Pharmacokinetic parameters, including AUC0-t, AUC0-inf and Cmax
21 samples over 144 hours in each period

Secondary Outcomes (1)

Pharmacokinetic parameters, including t1/2, Mean residence time, Terminal Elimination Rate Constant, and Tmax
21 samples over 144 hours in each period

Study Arms (1)

Ivermectin

EXPERIMENTAL

Ivermectin

Drug: ivermectin

Interventions

ivermectinDrug

Each subject will receive single doses of (i) 30 ml ivermectin oral solution (30 mg) and (ii) 10 x 3 mg tablets of ivermectin (30 mg) in 2 separate dosing periods with a 14 day wash-out period. Doses will be administered after an overnight fast.

Also known as: Stromectol

Ivermectin

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 50 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

BMI \<= 30 kg/m2 Weight between 50 and 90 kg
Non-smokers, or smokers of fewer than 10 cigarettes per day

Sponsors & Collaborators

Johnson & Johnson Consumer and Personal Products Worldwide
Industrylead

Study Sites (1)

Shandon Clinic

Cork, Co. Cork, Ireland

MeSH Terms

Conditions

Fasting

Interventions

Ivermectin

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

MacrolidesPolyketidesLactonesOrganic Chemicals

Study Officials

Jerry Cottrell
McNeil UK
STUDY DIRECTOR

Enrollment

24 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: NONE
Purpose: BASIC SCIENCE
Intervention Model: CROSSOVER
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

June 15, 2009

First Posted

June 16, 2009

Study Start

March 2005

Date type not reported

This date has not been verified as actual or estimated.

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Clinically normal medical history and physical exam findings

Negative screening results for protocol-specified drugs of abuse

Negative HIV and Hepatitis B and C tests

Appropriate use of contraception and negative pregnancy test

Ability to comprehend and communicate effectively with investigative staff

Ability to give written informed consent

You may not qualify if:

pregnant or nursing subjects
subjects who lived in region endemic for certain parasitic worm diseases
any protocol-specified vital sign or medical history that would preclude participation in the trial, including, but not limited to recent blood donation (or loss) and positive screens for HIV, Hepatitis B, or Hepatitis C
Any indication of current or previous abuse of alcohol, solvents or drugs
Intake of grapefruit products within 7 days before the start of the study
Intake of methylxanthine-containing beverages within 24 hours prior to each study period or quantities of methylxanthine or alcohol-containing beverages which, in the opinion of the Investigator are abnormal (more than 5 cups or glasses of tea, coffee, cola, chocolate etc. per day or more than 20 g alcohol/day)
Patients with a known or suspected intestinal helminth infection
Patients with a known hypersensitivity to any component of the Ivermectin product.
Smoking or alcohol consumption greater than protocol-specified levels
Protocol-specified contraindication to blood sampling
Acute or chronic medical, dietary or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the subject inappropriate for entry into this trial

Contact the study team to confirm eligibility.

Primary Completion

May 2005

Actual (reported)

Study Completion

September 2005

Actual (reported)

Last Updated

October 6, 2011

Record last verified: 2011-10

Source record

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Source: ClinicalTrials.gov.

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Registry identifier: NCT00921154
Data provider: ClinicalTrials.gov
Source updated: 2011-10-06
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:27:12 UTC

Locations

IE(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

Ivermectin

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations