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Ivermectin Solution Bioequivalence Study - With Food (Repeat)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00921219
Recruitment Status : Completed
First Posted : June 16, 2009
Last Update Posted : October 6, 2011
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide

Tracking Information
First Submitted Date  ICMJE June 15, 2009
First Posted Date  ICMJE June 16, 2009
Last Update Posted Date October 6, 2011
Study Start Date  ICMJE September 2005
Actual Primary Completion Date November 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 15, 2009)
Pharmacokinetic parameters, including AUC0-t, AUC0-inf and Cmax [ Time Frame: 21 samples over 144 hours in each period, with 14-day washout ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 15, 2009)
Pharmacokinetic parameters, including t1/2, MRT=Mean residence time kel = Terminal Elimination Rate Constant, Tmax [ Time Frame: 21 samples over 144 hours in each period with a 14-day washout ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ivermectin Solution Bioequivalence Study - With Food (Repeat)
Official Title  ICMJE Ivermectin Solution Bioequivalence Study - With Food (Repeat)
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 a standard meal. 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 20 minutes after a standard breakfast. Doses will 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE Drug: ivermectin
Each subject will receive single doses of (i) 22.5 ml ivermectin oral solution (22.5 mg) and (ii) 10 x 3 mg tablets of ivermectin (30 mg) in 2 separate dosing periods. Doses will be administered 20 minutes after a standard breakfast.
Other Name: Stromectol
Study Arms  ICMJE Experimental: Ivermectin
ivermectin
Intervention: Drug: ivermectin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 15, 2009)
34
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2005
Actual Primary Completion Date November 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male and female volunteers
  • Aged between 18 and 50 years
  • 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
  • Clinically normal findings on physical examination
  • Clinically normal blood pressure ( >/= 100/60 for males; >/= 90/50 for females; </= 140/90 for both)
  • Electrocardiogram recording (12-lead) within the normal range
  • Clinically normal findings for haematology and clinical chemistry of blood and urine, or showing clinically insignificant deviations only
  • negative screening results (within the 14 days before study start) for drug of abuse, including opiates, cannabinoids, amphetamines, methamphetamine, benzodiazepines and cocaine
  • Negative HIV and Hepatitis B and C tests (within the 14 days before study start)
  • Appropriate use of an effective method of contraception (female volunteers only)
  • Negative pregnancy test (female volunteers only)
  • Ability to comprehend and communicate effectively with the Investigator and staff
  • Ability to give written informed consent

Exclusion Criteria:

  • Illness within 14 days before the start of the study
  • Hospitalisation within 3 months before the start of the study (at the discretion of the Investigator)
  • Participation in a clinical trial in which blood was taken within 16 weeks before the start of the study
  • Participation in a clinical trial in which a volume of blood exceeding 500 ml was taken within 12 months before the start of the study
  • Donation of blood or plasma within 90 days before the start of the study
  • Any indication of current or previous abuse of alcohol, solvents or drugs
  • Treatment with a full or regular course of medication during the 28 days before the start of the study or with any proscribed medication during the 14 days before the start of the study
  • Use of alcohol on study days or within 24 hours prior to commencement of each study period
  • 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
  • Intake of quantities of methylxanthine or alcohol-containing beverages which, in the opinion of the Investigator are abnormal (habitually taking more than 5 cups or glasses of tea, coffee, cola, chocolate etc. per day or habitually taking more than 20 g alcohol/day)
  • Patient is pregnant, or lactating/breastfeeding (female volunteers only) Diet, which in the opinion of the Investigator, deviates from a normal diet (e.g. vegans)
  • Patients who have resided in areas of Africa known to be endemic for Onchocerca volvulus (onchocerciasis or river blindness), wuchereria bancrofti (lymphatic filariasis), Loa loa or other microfilaremic disease
  • Patients with a known or suspected intestinal helminth infection, such as Strongyloides stercoralis or other intestinal helminth
  • Patients with a known hypersensitivity to any component of the Ivermectin product
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00921219
Other Study ID Numbers  ICMJE SCO2005
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Johnson & Johnson Consumer and Personal Products Worldwide
Study Sponsor  ICMJE Johnson & Johnson Consumer and Personal Products Worldwide
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jerry Cottrell McNeil UK
PRS Account Johnson & Johnson Consumer and Personal Products Worldwide
Verification Date October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP