- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05082753
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
December 12, 2023 updated by: Humanis Saglık Anonim Sirketi
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Amman, Jordan
- ACDIMA Biocenter
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- The subject is aged between eighteen to fifty years (18 - 50), both inclusive.
- The subject is within the limits for his height & weight as defined by the body mass index range (18.5 - 30.0 Kg/m2).
- The subject is willing to undergo the necessary pre- & post- medical examinations set by this study.
- The results of medical history, physical examination, vital signs & conducted medical laboratory tests are normal as determined by the clinical investigator.
- The subject tested negative for hepatitis (B & C) viruses and human immunodeficiency virus (HIV).
- There is no evidence of psychiatric disorder, antagonistic personality, and poor motivation, emotional or intellectual problems likely to limit the validity of consent to participate in the study or limit the ability to comply with protocol requirements.
- The subject is able to understand and willing to sign the informed consent form.
- For female subjects: negative pregnancy test and the woman is using two reliable contraception methods
- The subject has normal cardiovascular system & ECG recording.
- The subject kidney functions test and liver enzymes (AST & ALT enzymes) are within normal range.
Exclusion Criteria:
- The subject is a heavy smoker (more than 10 cigarettes per day).
- The subject has suffered an acute illness one week before dosing.
- The subject has a history of or concurrent abuse of alcohol.
- The subject has a history of or concurrent abuse of illicit drugs.
- The subject has a history of hypersensitivity and/or contraindications to the study drug and any related compounds.
- The subject has been hospitalized within three months before the study or during the study.
- The subject is vegetarian.
- The subject has consumed caffeine or xanthine containing beverages or foodstuffs within two days before dosing and until 72 hours after dosing in all study periods.
- The subject has taken a prescription medication within two weeks or even an over the counter product (OTC) within one week before dosing in each study period and any time during the study, unless otherwise judged acceptable by the clinical investigator.
- The subject has taken grapefruit containing beverages or foodstuffs within seven (7) days before first dosing and any time during the study.
- The subject has been participating in any clinical study (e.g. pharmacokinetics, bioavailability and bioequivalence studies) within the last 80 days prior to the present study.
- The subject has donated blood within 80 days before first dosing.
- The subject has a history or presence of cardiovascular, pulmonary, renal, hepatic, gastrointestinal, hematological, endocrinal, immunological, dermatological, neurological, musculoskeletal or psychiatric diseases.
- The subject has consumed drugs or foodstuffs that may affect pharmacological or pharmacokinetic properties (for example: barbiturates (such as phenobarbital, butalbital), benzodiazepines (such as clonazepam, lorazepam), sodium oxybate (GHB), valproic acid, warfarin.) two weeks before dosing, during the study and two weeks after dosing.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ivermectin tablets (3 mg Ivermectin)
|
Two Ivermectin tablets were administered orally.
Two Ivermectin tablets were administered orally.
|
Active Comparator: Stromectol ® tablets (3 mg Ivermectin)
|
Two Ivermectin tablets were administered orally.
Two Ivermectin tablets were administered orally.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum observed plasma concentration (Cmax)
Time Frame: 72 hours
|
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)
Time Frame: 72 hours
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tmax
Time Frame: 72 hours
|
The descriptive statistics including Maximum, Minimum and Median values will be measured for Tmax
|
72 hours
|
Blood pressure (safety and tolerability)
Time Frame: 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
|
Clinically significant abnormal deviations.
Normal range of blood pressure > 90/60 and <140/90 mmHg.
|
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)
Time Frame: 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
|
Clinically significant abnormal deviations.
Normal range of Pulse 60-100 b/m
|
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)
Time Frame: at pre-dosing; 4, 12, 24, 48 and 72 hours post-dosing, ±45 minutes of scheduled time
|
Clinically significant abnormal deviations.
Normal range of temperature 36.5-37.5 ºC
|
at pre-dosing; 4, 12, 24, 48 and 72 hours post-dosing, ±45 minutes of scheduled time
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Hakan Gürpınar, Humanis Saglık
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 19, 2020
Primary Completion (Actual)
December 21, 2020
Study Completion (Actual)
December 21, 2020
Study Registration Dates
First Submitted
September 13, 2021
First Submitted That Met QC Criteria
October 16, 2021
First Posted (Actual)
October 19, 2021
Study Record Updates
Last Update Posted (Actual)
December 13, 2023
Last Update Submitted That Met QC Criteria
December 12, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 988-2020
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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