Clinical Trials Logo
  1. Home
  2. Drug Use
  3. NCT05468879

Bioequivalence Study of 3 mg Glimepiride Tablet in Indonesia Healthy Subjects

Drug Use Clinical Trial

Official title:
Bioequivalence Study of 3 mg Glimepiride Tablet in Indonesia Healthy Subjects

Clinical Trial 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05468879
Study type Interventional
Source PT Harsen Laboratories
Contact
Status Completed
Phase N/A
Start date September 21, 2020
Completion date January 6, 2021
View Details
See also
  Status Clinical Trial Phase
Completed NCT02293057 - Gender-Responsive Drug Use Treatment for Juvenile Justice Girls N/A
Completed NCT01941108 - Technology-Enhanced Peer Navigation to Improve IDUs' Engagement in HIV Care N/A
Completed NCT01380613 - Neighborhoods, Networks, Depression, and HIV Risk Phase 2
Withdrawn NCT00914719 - Alcohol Use and Sexual Risk: An Intervention N/A
Recruiting NCT03671629 - Pharmacist Intervention to Reduce Drug-related Readmissions Among the Elderly N/A
Completed NCT03290391 - Linking Infectious and Narcology Care-Part II Phase 4
Completed NCT04008927 - A Community-based Intervention Among Active Drug Users in Montpellier N/A
Completed NCT03627546 - HCV Seek, Test and Rapid Treatment for Young PWID N/A
Recruiting NCT05380765 - Developing a Positive Approach to Substance Use Prevention in North American Indian Adolescents N/A
Not yet recruiting NCT03967262 - Secondary Prevention and Recidivism Reduction in Trauma Patients N/A
Completed NCT03079856 - Drug Use and Sexual Risk Behaviors Among Emerging Adults in the ER N/A
Completed NCT03855410 - Preventing Cigarette Use Among Urban Youth Via an M-Health Primary Care Preventive Intervention N/A
Terminated NCT02457949 - The Impact of Alternative Social Assistance Disbursement on Drug-related Harm N/A
Completed NCT06238154 - Flurbiprofen Tablet vs Spray In Oral Soft Tissue Wounds Phase 4
Terminated NCT04436055 - Intergenerational Effects of Paternal Periconceptional Cannabis and Other Drug Use (EPIC)
Recruiting NCT04717856 - Evaluation of the Use of the GenXpert to Detect Hepatitis C RNA N/A
Completed NCT00249496 - Employment-based Reinforcement to Motivate Drug Abstinence in the Treatment of Drug Addiction. - 1 N/A
Recruiting NCT05597865 - Assessing the Feasibility of Economic Approaches to Prevent Substance Abuse Among Adolescents N/A
Completed NCT05553054 - Drug Wastage : Observational Study in Intensive Care Units in France
Completed NCT03718520 - The Influence of in Utero Cannabis Exposure on Neonatal Brain Morphology and Structural Connectivity