Sponsor study identifier
interventional
34
0 countries
N/A
Study Start
September 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2005
Actual (reported)Study Completion
November 2005
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2005
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2005
Date type not reportedThis date has not been verified as actual or estimated.
November 2005
Actual (reported)November 2005
Actual (reported)June 15, 2009
Actual (reported)June 16, 2009
Actual (reported)Pharmacokinetic parameters, including AUC0-t, AUC0-inf and Cmax
21 samples over 144 hours in each period, with 14-day washout
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
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Jerry Cottrell
McNeil UK
34 participants (actual enrollment reported by the registry).
First Submitted
June 15, 2009
First Posted
June 16, 2009
Study Start
September 2005
Date type not reportedThis date has not been verified as actual or estimated.
Pharmacokinetics of 3 Formulations of Ibuprofen Suppositories
Contact the study team to confirm eligibility.
Primary Completion
November 2005
Actual (reported)Study Completion
November 2005
Actual (reported)Last Updated
October 6, 2011
Record last verified: 2011-10
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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