Ivermectin Solution Bioequivalence Study - With Food
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.
|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 Male and Female Volunteers After Food|
- Pharmacokinetic parameters, including AUC0-t, AUC0-inf, and Cmax [ Time Frame: 21 samples over 144 hours in each period, with a 14-day washout ] [ Designated as safety issue: No ]
- Pharmacokinetic parameters, including t1/2, Mean residence time (MRT), Terminal Elimination Rate Constant (kel) and Tmax [ Time Frame: 21 samples over 144 hours in each period, with a 14-day washout ] [ Designated as safety issue: No ]
|Study Start Date:||February 2005|
|Study Completion Date:||April 2005|
|Primary Completion Date:||April 2005 (Final data collection date for primary outcome measure)|
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. Doses will be administered 20 minutes after a standard breakfast.
Other Name: Stromectol
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 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.