Bioequivalence Study of 3 mg Glimepiride Tablet in Indonesia Healthy Subjects

NCT05468879 | Completed DMC

• 1 other identifier: 540/STD/PML/2020
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Drug Use

Keywords

Bioequivalence study; Glimepiride; Indonesia; cross-over design study; pharmacokinetics

Outcome Measures

Primary Outcomes (2)

• Maximum plasma concentration (Cmax)

  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)

  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 Outcomes (2)

• 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

• 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

Study Arms (2)

Glimepiride 3 mg Tablet

EXPERIMENTAL

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

Drug: Glimepiride

Amaryl® 3 mg tablet

ACTIVE COMPARATOR

Participants received Amaryl® 3 mg tablet (Glimepiride 3 mg) with 240 mL of 20% glucose solution

Drug: Amaryl®

Interventions

Glimepiride DRUG

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.

Glimepiride 3 mg Tablet

Amaryl® DRUG

Amaryl®

Amaryl® 3 mg tablet

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• PT Harsen Laboratories: lead
• PT Pharma Metric Labs: collaborator

Study Sites (1)

PT Pharma Metric Labs

Jakarta, DKI Jakarta, 10520, Indonesia

Location

Related Publications (4)

• 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.

  PMID: 20685507 BACKGROUND

• 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.

  PMID: 25237332 BACKGROUND

• 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.

  PMID: 32092631 BACKGROUND

• 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.

  PMID: 17252706 RESULT

Related Links

• Amaryl® (Glimepiride) Tablet 1,2, and 4 mg, Product Monograph

MeSH Terms

Interventions

glimepiride

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: July 19, 2022
• First Posted: July 21, 2022
• Study Start: September 21, 2020
• Primary Completion: October 23, 2020
• Study Completion: January 6, 2021
• Last Updated: July 21, 2022

Record last verified: 2022-07

Locations

ID (1)