Bioequivalence Study of 3 mg Glimepiride Tablet in Indonesia Healthy Subjects

Sponsor

PT Harsen Laboratories (Industry)

Overall Status

Completed

CT.gov ID

NCT05468879

Collaborator

PT Pharma Metric Labs (Industry)

Enrollment

Location

Arms

3.5

Actual Duration (Months)

9.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Drug Use	Drug: Glimepiride Drug: Amaryl®	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

34 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Randomized, single blind, two-period, single dose, cross-over study with one week washout period under fasted conditionRandomized, single blind, two-period, single dose, cross-over study with one week washout period under fasted condition

Masking:

Double (Participant, Investigator)

Primary Purpose:

Basic Science

Official Title:

Bioequivalence Study of 3 mg Glimepiride Tablet in Indonesia Healthy Subjects

Actual Study Start Date :

Sep 21, 2020

Actual Primary Completion Date :

Oct 23, 2020

Actual Study Completion Date :

Jan 6, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Glimepiride 3 mg Tablet Participants received Glimepiride 3 mg Tablet with 240 mL of 20% glucose solution	Drug: Glimepiride 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	Drug: Amaryl® Amaryl®

Arm

Intervention/Treatment

Experimental: Glimepiride 3 mg Tablet

Participants received Glimepiride 3 mg Tablet with 240 mL of 20% glucose solution

Drug: Glimepiride

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

Drug: Amaryl®

Amaryl®

Outcome Measures

Primary Outcome Measures

Maximum plasma concentration (Cmax) [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
Area Under Curve from 0 to 30 hours (AUCt) [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

Secondary Outcome Measures

Maximum plasma concentration (Cmax) [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
Area Under Curve from 0 to 30 hours (AUCt) [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.