Clinical Trials Logo
  1. Home
  2. Drug Use
  3. NCT04982861

Bioequivalence Study of Cefixime Trihydrate Dry Syrup in Indonesia Healthy Volunteers

Drug Use Clinical Trial

Official title:
Bioequivalence Study of Cefixime Trihydrate 100 mg/5 mL DS in Indonesia Healthy Volunteers

Clinical Trial Summary

This study was conducted to investigate whether 100 mg/5 mL cefixime trihydrate dry syrup manufactured by PT. Bernofarm, Indonesia was bioequivalent to its reference product, 100 mg/5 mL Suprax® dry syrup manufactured by Odan Laboratories Ltd., Canada registered trademark of Astellas Pharma Inc., Japan.

Clinical Trial Description

Twenty two healty subjects were given a single dose of 100 mg/5 mL cefixime trihydrate dry syrup or or 100 mg/5 mL Suprax® dry syrup with 240 mL of water. Then the blood samples for cefixime trihydrate was drawn and analyzed using HPLC. All subjects sample plasma were analyzed for pharmacokinetic evaluation. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04982861
Study type Interventional
Source PT Bernofarm
Contact
Status Completed
Phase N/A
Start date June 15, 2020
Completion date August 25, 2020
View Details
See also
  Status Clinical Trial Phase
Completed NCT05468879 - Bioequivalence Study of 3 mg Glimepiride Tablet in Indonesia Healthy Subjects N/A
Not yet recruiting NCT06395129 - Low Dead-space Injecting Equipment Distribution Program for People Who Inject Drugs in Low- and Middle-income Countries
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Withdrawn NCT00914719 - Alcohol Use and Sexual Risk: An Intervention N/A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