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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
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