NCT04982861

Bioequivalence Study of Cefixime Trihydrate Dry Syrup in Indonesia Healthy Volunteers

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: PT Bernofarm · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Drug Use

Interventions

Type	Name	Description
DRUG	Cefixime Trihydrate 100 mg/5 mL Dry Syrup	Participants received a single dose of 5 mL of cefixime dry syrup with 240 mL of water
DRUG	Suprax 100 MG in 5 mL Oral Suspension	Participants received a single dose of 5 mL of Suprax with 240 mL of water

Timeline

• Start date: 2020-06-15
• Primary completion: 2020-08-15
• Completion: 2020-08-25
• First posted: 2021-07-29
• Last updated: 2021-08-11

Locations

1 site across 1 country: Indonesia