Bioequivalence Study of Cefixime Trihydrate Dry Syrup in Indonesia Healthy Volunteers

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Drug Use

Intervention / Treatment
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* Drug: Cefixime Trihydrate 100 mg/5 mL Dry Syrup
* Drug: Suprax 100 MG in 5 mL Oral Suspension


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male or female subjects Had read the subject information and signed informed consent documents Age 18 - 55 years Body mass index between 18-25 kg/m2 Had a normal electrocardiogram Blood pressure within normal range (systolic 90-120 mmHg and diastolic 60-80 mmHg) Heart rate within normal range (60-100 bpm) The absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening Exclusion Criteria: those who were pregnant and/or nursing women. those who had a history of contraindication or hypersensitivity to cefixime, other antibiotics or other ingredients in the drugs or a history of serious allergic reaction to any drug, significant allergic disease or allergic reaction those who had a history or present medical condition which might significantly influence the pharmacokinetics of the study drug, e.g. chronic gastrointestinal disease, diarrhea, gastric surgery, renal insufficiency, hepatic dysfunction, and cardiovascular disease. those who had a history or presence of any coagulation disorder or clinically significant hematology abnormalities. those who were using any medication (prescription or non-prescription drug, food supplement, herbal medicine), particularly the medication known to affect the pharmacokinetics of the study drug, within one week prior to the drug administration day. those who had participated in any clinical study within 3 months prior to the study (< 90 days). those who had donated or lost 300 ml (or more) of blood within 3 months prior to the study. those who smoked more than 10 cigarettes a day. those who had a history of traveling to another city within the last 14 days those with a history of direct contact with a COVID-19 positive person in the subject neighborhood those with a history or presence of sore throat, fever (with temperature more than 37°C) or short of breath within the last 14 days those who were positive to COVID-19 those who were positive to HIV, HBsAg, and HCV tests (to be kept confidential). those with a history of drug or alcohol abuse within 12 months prior to screening for this study. those who were unlikely to comply with the protocol, e.g uncooperative attitude, inability to return for follow-up visits, poor venous access.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomized, single-blind, two-period, single dose, cross-over design in 22 healthy subjects under fasting condition.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cefixime trihydrate 100 mg/5 mL dry syrup<br>Cefixime trihydrate 100 mg/5 mL dry syrup was dissolved by 20 mL of water split in 2 portions. Then the drug was shaken well for at least 30 seconds at each addition of water. | Drug: Cefixime Trihydrate 100 mg/5 mL Dry Syrup<br>* Participants received a single dose of 5 mL of cefixime dry syrup with 240 mL of water<br>|
| Active Comparator: Suprax® 100 mg/5 mL dry syrup<br>Suprax® 100 mg/5 mL dry syrup was dissolved by 33 mL of water split in 2 portions. Then the drug was shaken well for at least 30 seconds at each addition of water. | Drug: Suprax 100 MG in 5 mL Oral Suspension<br>* Participants received a single dose of 5 mL of Suprax with 240 mL of water<br>* Other names: Cefixime Trihydrate 100 mg/5 mL Dry Syrup;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric Mean Ratio | The ratio between test drug and reference drug | 32 hours | 
| 90% confidence intervals | The two products are considered bioequivalent when the 90% confidence intervals of the cefixime trihydrate geometric mean ratio between test and reference product fall within the range of 80.00-125.00% for AUCt and Cmax. | 32 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics parameter | Maximum plasma concentration (Cmax) | 32 hours | 
| Pharmacokinetics parameter | Area Under Curve from 0 to 32 hours (AUCt) | pre-dose at (0 h) 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bioequivalence study, cefixime trihydrate, dry syrup, Indonesia