NCT00921154

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 an overnight fast .The study is designed in accordance with the EU Note for Guidance on the Investigation of Bioavailability and Bioequivalence 2001.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Mar 2005

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2005

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

June 15, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 16, 2009

Completed
Last Updated

October 6, 2011

Status Verified

October 1, 2011

Enrollment Period

2 months

First QC Date

June 15, 2009

Last Update Submit

October 4, 2011

Conditions

Healthy

Keywords

therapeutic equivalencypharmacokineticsfastingHealthy Volunteers

Outcome Measures

Primary Outcomes (1)

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

    21 samples over 144 hours in each period

Secondary Outcomes (1)

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

    21 samples over 144 hours in each period

Study Arms (1)

Ivermectin

EXPERIMENTAL

Ivermectin

Drug: ivermectin

Interventions

ivermectinDRUG

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.

Also known as: Stromectol
Ivermectin

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shandon Clinic

Cork, Co. Cork, Ireland

Location

MeSH Terms

Conditions

Fasting

Interventions

Ivermectin

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

MacrolidesPolyketidesLactonesOrganic 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

March 1, 2005

Primary Completion

May 1, 2005

Study Completion

September 1, 2005

Last Updated

October 6, 2011

Record last verified: 2011-10

Locations

IE(1)