Ivermectin Solution Bioequivalence Study - Fasted

• Status: Completed
• Trial end date: 2005-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
• Treatments: Ivermectin

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