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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ivermectin | Experimental | ivermectin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameters, including AUC0-t, AUC0-inf and Cmax | 21 samples over 144 hours in each period, with 14-day washout |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jerry Cottrell | McNeil UK | Study Director |
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| ID | Term |
|---|---|
| D007559 | Ivermectin |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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