Status:
COMPLETED
Ivermectin Solution Bioequivalence Study - Fasted
Lead Sponsor:
Johnson & Johnson Consumer and Personal Products Worldwide
Conditions:
Healthy
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
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 ...
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 f...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2005
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00921154
Start Date
March 1 2005
End Date
September 1 2005
Last Update
October 6 2011
Active Locations (1)
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1
Shandon Clinic
Cork, Co. Cork, Ireland