- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05468879
Bioequivalence Study of 3 mg Glimepiride Tablet in Indonesia Healthy Subjects
July 20, 2022 updated by: PT Harsen Laboratories
The study was conducted toinvestigate whether the bioavailability of 3 mg Glimepiride Tablet Manufactured by PT.
Harsen Laboratories was bioequivalent to the reference product, 3 mg Amaryl® Tablet Manufactured by PT.
Aventis Indonesia Pharma, Indonesia.
Study Overview
Detailed Description
The study was conducted following an oral administration of one tablet of the test drug (3 mg Glimepiride Tablet) or one tablet of the reference drug (3 mg Amaryl® Tablet ).
Blood samples were drawn before dosing (0 h) and at 15, 30, 45 minutes, and 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 9, 12, 18, 24, and 30 hours after drug administration.
The entire subjects were given 60 mL of 20% glucose solution to minimize hypoglycemic effects at 15, 30, 45 minutes, and 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75 and 4 hours after drug administration.
Following a washout period of one week, this procedure was repeated using the alternate drug.
The plasma concentrations of glimepiride were determined by means of LC-MS/MS system.
The LLOQ is 1.99 ng/mL of glimepiride.
The pharmacokinetic parameters used in this study were area under the concentration-time curve of glimepiride from time zero to 30 hours (AUCt), area under the concentration-time curve from time zero to infinite (AUCinf), maximum concentration (Cmax), time required to reach the maximum concentration (tmax) and the elimination half life (t½).
Study Type
Interventional
Enrollment (Actual)
34
Phase
- Not Applicable
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
-
-
DKI Jakarta
-
Jakarta, DKI Jakarta, Indonesia, 10520
- PT Pharma Metric Labs
-
-
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 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- healthy male and female
- had read the subject information and signed informed consent documents
- were age between 18 to 55 years
- had body mass index between 18 to 25 kg/m2
- had a normal electrocardiogram
- had normal blood pressure (systolic was ranged between 90 to 120 mmHg and diastolic was ranged between 60 to 80 mmHg)
- had normal heart rate (ranged between 60 to 100 bpm)
- have no significant disease in medical history; have no significant abnormal values in laboratory and physical examination during screening
- had acceptance to use protection (condom) during intercourse with their spouse throughout the study
Exclusion Criteria:
- Pregnant and/or nursing woman.
- Those with a history of contraindication or hypersensitivity to glimepiride, other antidiabetic agent or other ingredients in the study products or a history of serious allergic reaction to any drug, significant allergic disease or allergic reaction.
- Those with a history or presence of medical condition which might significantly influence the pharmacokinetics of the study drug, e.g. chronic gastrointestinal disease, diarrhea, gastric surgery, renal insufficiency, hepatic dysfunction or cardiovascular disease.
- Those with a history or presence of any coagulation disorder or clinically significant hematology abnormalities.
- Those who using any medication (prescription or non-prescription drug, food supplement, herbal medicine), particularly the medication known to affect the pharmacokinetic of the study drug, within one week prior to the drug administration day.
- Those who had participated in any clinical study within 3 months prior to the study (< 90 days).
- Those who donated or lost 300 mL (or more) of blood within 3 months prior to the study.
- Those who smoked more than 10 cigarettes a day
- Those with a history of travelling to another city within the last 14 days
- Those with a history of direct contact with a COVID-19 positive person in the subject's neighborhood
- Those with a history or present of sore throat, fever (with temperature more than 37°C) or dyspnea within the last 14 days
- Those who reactive to anti SARS CoV-2 test
- Those who were positive to HIV, HBsAg, and HCV tests (to be kept confidential).
- Those with a history of drug or alcohol abused within 12 months prior to screening for this study
- Those who were unlikely to comply with the protocol, e.g uncooperative attitude, inability to return for follow up visits, poor venous access.
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: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Glimepiride 3 mg Tablet
Participants received Glimepiride 3 mg Tablet with 240 mL of 20% glucose solution
|
Glimepiride is a sulfonylurea, indicated as an adjunct to proper dietary management, exercise and weight reduction to lower the blood glucose in patients with type 2 diabetes whose hyperglycemia cannot be controlled by diet and exercise alone.
|
Active Comparator: Amaryl® 3 mg tablet
Participants received Amaryl® 3 mg tablet (Glimepiride 3 mg) with 240 mL of 20% glucose solution
|
Amaryl®
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum plasma concentration (Cmax)
Time Frame: before dosing (0 hour) and at 15, 30, 45 minutes, and 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 9, 12, 18, 24, and 30 hours after drug administration
|
90% Confidence Interval
|
before dosing (0 hour) and at 15, 30, 45 minutes, and 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 9, 12, 18, 24, and 30 hours after drug administration
|
Area Under Curve from 0 to 30 hours (AUCt)
Time Frame: before dosing (0 hour) and at 15, 30, 45 minutes, and 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 9, 12, 18, 24, and 30 hours after drug administration
|
90% Confidence Interval
|
before dosing (0 hour) and at 15, 30, 45 minutes, and 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 9, 12, 18, 24, and 30 hours after drug administration
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum plasma concentration (Cmax)
Time Frame: before dosing (0 hour) and at 15, 30, 45 minutes, and 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 9, 12, 18, 24, and 30 hours after drug administration
|
Pharmacokinetics Parameter
|
before dosing (0 hour) and at 15, 30, 45 minutes, and 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 9, 12, 18, 24, and 30 hours after drug administration
|
Area Under Curve from 0 to 30 hours (AUCt)
Time Frame: before dosing (0 hour) and at 15, 30, 45 minutes, and 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 9, 12, 18, 24, and 30 hours after drug administration
|
Pharmacokinetics Parameter
|
before dosing (0 hour) and at 15, 30, 45 minutes, and 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 9, 12, 18, 24, and 30 hours after drug administration
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Liu Y, Zhang MQ, Zhu JM, Jia JY, Liu YM, Liu GY, Li S, Weng LP, Yu C. Bioequivalence and pharmacokinetic evaluation of two formulations of glimepiride 2 mg: a single-dose, randomized-sequence, open-label, two-way crossover study in healthy Chinese male volunteers. Clin Ther. 2010 May;32(5):986-95. doi: 10.1016/j.clinthera.2010.04.016.
- Jung SH, Chae JW, Song BJ, Kwona KI. Bioequivalence Comparison of Two Formulations of Fixed-Dose Combination Glimepiride/Metformin (2/500 mg)Tablets in Healthy Volunteers. Iran J Pharm Res. 2014 Spring;13(2):365-71.
- Zhu J, Li Y, Xiang Y, Zhou L, Li Y. Magnetic solid phase extraction followed with LC-MS/MS for determination of glimepiride in beagle dog plasma and its application to bioequivalence study. J Pharm Biomed Anal. 2020 May 30;184:113180. doi: 10.1016/j.jpba.2020.113180. Epub 2020 Feb 15.
- Jovanovic D, Stojsic D, Zlatkovic M, Jovic-Stosic J, Jovanovic M. Bioequivalence assessment of the two brands of glimepiride tablets. Vojnosanit Pregl. 2006 Dec;63(12):1015-20. doi: 10.2298/vsp0612015j.
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)
September 21, 2020
Primary Completion (Actual)
October 23, 2020
Study Completion (Actual)
January 6, 2021
Study Registration Dates
First Submitted
July 19, 2022
First Submitted That Met QC Criteria
July 20, 2022
First Posted (Actual)
July 21, 2022
Study Record Updates
Last Update Posted (Actual)
July 21, 2022
Last Update Submitted That Met QC Criteria
July 20, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 540/STD/PML/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
product manufactured in and exported from the U.S.
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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