Ivermectin Solution Bioequivalence Study - Fasted

NCT ID: NCT00921154

Last Updated: 2011-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-03-31
• Study Completion Date: 2005-09-30

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.

Detailed Description

Ivermectin is an antiparasitic medicine (i.e. a medicine used to eliminate parasitic worms) for oral administration, and is approved in the US and some other countries in a tablet form. A new liquid formulation of ivermectin has been developed to facilitate dosing. This is a single dose, randomised, crossover study in healthy adult male and female volunteers, with doses taken after an overnight fast. Doses will be separated by washout period of at least 14 days. Twenty-one blood samples will be taken from each volunteer over 144 hours in each period. Concentrations of ivermectin in plasma will be measured using a validated chromatographic assay (LC-MS/MS). Standard pharmacokinetic parameters will be obtained and bioequivalence on the basis of rate and extent of drug absorption will be assessed.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Ivermectin

Ivermectin

Group Type: EXPERIMENTAL

ivermectin

Intervention Type: DRUG

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.

Interventions

ivermectin

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.

Intervention Type: DRUG

Other Intervention Names

Stromectol

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johnson & Johnson Consumer and Personal Products Worldwide

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jerry Cottrell

Role: STUDY_DIRECTOR

McNeil UK

Locations

Shandon Clinic

Cork, Co. Cork, Ireland

Countries

Ireland

Other Identifiers

SCO2704

Identifier Type: -

Identifier Source: org_study_id