Randomized, Two-way, Two-period, Single Oral Dose, Open-label, Crossover, Bioequivalence Study to Compare Two Tablets of Ivermectin Tablets (3 mg Ivermectin) Versus Two Tablets of Stromectol ® Tablets (3 mg Ivermectin), in Healthy Subjects Under Fasting Conditions
Sponsor study identifier
interventional
50
1 country
1
Study Start
November 19, 2020
Actual (reported)Primary Completion
December 21, 2020
Actual (reported)Study Completion
December 21, 2020
Actual (reported)Randomized, two-way, two-period, single oral dose, open-label, crossover, bioequivalence study to compare two tablets of Ivermectin tablets (3 mg Ivermectin) versus two tablets of Stromectol ® tablets (3 mg Ivermectin), in healthy subjects under fasting conditions.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 21, 2020
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 19, 2020
Actual (reported)December 21, 2020
Actual (reported)December 21, 2020
Actual (reported)September 13, 2021
Actual (reported)October 19, 2021
Actual (reported)Maximum observed plasma concentration (Cmax)
Statistical analysis of primary endpoints will include descriptive statistics, Analysis of Variance (ANOVA), and Confidence Interval (CI). The average bioequivalence of the products is concluded if the two-sided 90 % CI for the test to reference ratio of the population means is within 80.00 - 125.00 % for each of the Ln-transformed data for Cmax
72 hours
AUC0-72 (due to Ivermectin long half-life)
Statistical analysis of primary endpoints will include descriptive statistics, Analysis of Variance (ANOVA), and Confidence Interval (CI). The average bioequivalence of the products is concluded if the two-sided 90 % CI for the test to reference ratio of the population means is within 80.00 - 125.00 % for each of the Ln-transformed data for AUC0-72
72 hours
Tmax
72 hours
Blood pressure (safety and tolerability)
at pre-dosing; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48 and 72 hours post-dosing, ±45 minutes of scheduled time
Pulse (safety and tolerability)
at pre-dosing; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48 and 72 hours post-dosing, ±45 minutes of scheduled time
Temperature (safety and tolerability)
at pre-dosing; 4, 12, 24, 48 and 72 hours post-dosing, ±45 minutes of scheduled time
Two Ivermectin tablets were administered orally.
Two Ivermectin tablets were administered orally.
ACDIMA Biocenter
Amman, Jordan
Hakan Gürpınar
Humanis Saglık
50 participants (actual enrollment reported by the registry).
First Submitted
September 13, 2021
First Posted
October 19, 2021
Study Start
November 19, 2020
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
December 21, 2020
Actual (reported)Study Completion
December 21, 2020
Actual (reported)Last Updated
December 13, 2023
Record last verified: 2023-12
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Source: ClinicalTrials.gov.
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