In short
This article discusses a clinical trial conducted to evaluate the bioequivalence of a generic Cefixime Trihydrate dry syrup compared to its brand-name counterpart, Suprax®. The study aimed to determine if the generic version, manufactured by PT. Bernofarm in Indonesia, performs similarly to the reference product made by Odan Laboratories Ltd. in Canada. Understanding bioequivalence is crucial for ensuring that generic medications are as safe and effective as their brand-name counterparts.
At a glance
- Study Type
- Bioequivalence study
- Drug Tested
- Cefixime Trihydrate 100 mg/5 mL dry syrup
- Comparator
- Suprax® 100 mg/5 mL dry syrup
- Study Design
- Randomized, single-blind, two-period, single dose, cross-over
- Number of Participants
- 22 healthy volunteers
- Dosage
- Single 5 mL dose with 240 mL water
- Primary Outcomes
- Geometric Mean Ratio, 90% confidence intervals
- Secondary Outcomes
- Maximum plasma concentration (Cmax), Area Under Curve (AUCt)
- Analysis Method
- HPLC (High-Performance Liquid Chromatography)
- Bioequivalence Criteria
- 90% CI within 80.00-125.00% for AUCt and Cmax
What is Cefixime Trihydrate?
Cefixime Trihydrate is an antibiotic medication used to treat various bacterial infections. It belongs to a class of drugs called cephalosporins, which are similar to penicillin antibiotics. Cefixime Trihydrate is available in different forms, including a dry syrup formulation that is reconstituted (mixed with water) before use.
In the medical community, this medication is also known by its brand name Suprax®, which is manufactured by Odan Laboratories Ltd., Canada, and is a registered trademark of Astellas Pharma Inc., Japan.
How is Cefixime Trihydrate Administered?
Cefixime Trihydrate is typically administered as an oral suspension. The dry syrup needs to be reconstituted with water before use. Here's how it's prepared:
- For the test drug (Cefixime Trihydrate 100 mg/5 mL dry syrup): The medication is dissolved in 20 mL of water, split into 2 portions. The drug is then shaken well for at least 30 seconds after each addition of water.
- For the reference drug (Suprax® 100 mg/5 mL dry syrup): The medication is dissolved in 33 mL of water, also split into 2 portions. Similarly, it is shaken well for at least 30 seconds after each addition of water.
In the study, participants received a single dose of 5 mL of the reconstituted syrup (either the test drug or Suprax®) with 240 mL of water.
Bioequivalence Study
A bioequivalence study was conducted to investigate whether the 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.
Bioequivalence is a term used to describe when two medications are pharmaceutically equivalent and their effects can be expected to be essentially the same. This is important for ensuring that generic versions of medications work just as well as brand-name versions.
The study aimed to determine if the two products were bioequivalent by comparing their pharmacokinetic parameters. Pharmacokinetics refers to how the body processes a drug, including how it's absorbed, distributed, metabolized, and excreted.
Pharmacokinetics of Cefixime Trihydrate
The study focused on two main pharmacokinetic parameters:
- Maximum plasma concentration (Cmax): This is the highest concentration of the drug in the blood after administration.
- Area Under Curve from 0 to 32 hours (AUCt): This measure represents the total exposure to the drug over time.
Blood samples were collected at various time points (pre-dose at 0 hours and post-dose at 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, and 32 hours) to analyze these parameters.
Study Design and Methodology
The bioequivalence study was designed as follows:
- Study type: Randomized, single-blind, two-period, single dose, cross-over design.
- Participants: 22 healthy volunteers.
- Condition: Fasting (participants were not allowed to eat before taking the medication).
- Analysis method: Blood samples were analyzed using High-Performance Liquid Chromatography (HPLC), a technique used to separate, identify, and quantify components in a mixture.
The study aimed to determine if the two products were bioequivalent by calculating the geometric mean ratio and 90% confidence intervals. The two products are considered bioequivalent when the 90% confidence intervals of the cefixime trihydrate geometric mean ratio between the test and reference product fall within the range of 80.00-125.00% for AUCt and Cmax.
This type of study is crucial for ensuring that generic versions of medications are as safe and effective as their brand-name counterparts, providing patients with more affordable treatment options without compromising on quality or efficacy.