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Ivermectin Solution Bioequivalence Study - Fasted

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide
ClinicalTrials.gov Identifier:
NCT00921154
First received: June 15, 2009
Last updated: October 4, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: ivermectin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: A Single-dose, Randomised, Crossover Study to Compare the Rate and Extent of Absorption of Two Formulations of Ivermectin in Healthy, Fasting Male and Female Volunteers

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Consumer and Personal Products Worldwide:

Primary Outcome Measures:
  • Pharmacokinetic parameters, including AUC0-t, AUC0-inf and Cmax [ Time Frame: 21 samples over 144 hours in each period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetic parameters, including t1/2, Mean residence time, Terminal Elimination Rate Constant, and Tmax [ Time Frame: 21 samples over 144 hours in each period ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: March 2005
Study Completion Date: September 2005
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ivermectin
Ivermectin
Drug: 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.
Other Name: Stromectol

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00921154

Locations
Ireland
Shandon Clinic
Cork, Co. Cork, Ireland
Sponsors and Collaborators
Johnson & Johnson Consumer and Personal Products Worldwide
Investigators
Study Director: Jerry Cottrell McNeil UK
  More Information

No publications provided

Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide
ClinicalTrials.gov Identifier: NCT00921154     History of Changes
Other Study ID Numbers: SCO2704
Study First Received: June 15, 2009
Last Updated: October 4, 2011
Health Authority: Ireland: Irish Medicines Board

Keywords provided by Johnson & Johnson Consumer and Personal Products Worldwide:
therapeutic equivalency
pharmacokinetics
fasting
Healthy Volunteers

Additional relevant MeSH terms:
Ivermectin
Anti-Infective Agents
Antiparasitic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014