Ivermectin Solution Bioequivalence Study - With Food (Repeat)

NCT00921219 | Completed Phase 1

• 1 other identifier: SCO2005
• Study Type: interventional
• Target: 34
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy

Keywords

therapeutic equivalency; pharmacokinetics; food; Healthy volunteers

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetic parameters, including AUC0-t, AUC0-inf and Cmax

  21 samples over 144 hours in each period, with 14-day washout

Secondary Outcomes (1)

• Pharmacokinetic parameters, including t1/2, MRT=Mean residence time kel = Terminal Elimination Rate Constant, Tmax

  21 samples over 144 hours in each period with a 14-day washout

Study Arms (1)

Ivermectin

EXPERIMENTAL

ivermectin

Drug: ivermectin

Interventions

ivermectin DRUG

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.

Also known as: Stromectol

Ivermectin

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Consumer and Personal Products Worldwide: lead

MeSH Terms

Interventions

Ivermectin

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Jerry Cottrell

  McNeil UK

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2009
• First Posted: June 16, 2009
• Study Start: September 1, 2005
• Primary Completion: November 1, 2005
• Study Completion: November 1, 2005
• Last Updated: October 6, 2011

Record last verified: 2011-10