Bioequivalence Study of Cefixime Trihydrate Dry Syrup in Indonesia Healthy Volunteers

Not Applicable

Completed

• Conditions: Drug Use
• Interventions: Drug: Suprax 100 MG in 5 mL Oral Suspension; Drug: Cefixime Trihydrate 100 mg/5 mL Dry Syrup

• Registration Number: NCT04982861
• Lead Sponsor: PT Bernofarm

Brief 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.

Study Timeline

• Study Start: 2020-06-15
• Primary Completion: 2020-08-15
• Study Completion: 2020-08-25
• Study First Submitted: 2021-07-23
• Study First Submitted QC: 2021-07-23
• Study First Posted: 2021-07-29
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-04
• Last Update Posted: 2021-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

1. Healthy male or female subjects
2. Had read the subject information and signed informed consent documents
3. Age 18 - 55 years
4. Body mass index between 18-25 kg/m2
5. Had a normal electrocardiogram
6. Blood pressure within normal range (systolic 90-120 mmHg and diastolic 60-80 mmHg)
7. Heart rate within normal range (60-100 bpm)
8. The absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening

Exclusion Criteria

1. those who were pregnant and/or nursing women.
2. 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
3. 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.
4. those who had a history or presence of any coagulation disorder or clinically significant hematology abnormalities.
5. 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.
6. those who had participated in any clinical study within 3 months prior to the study (< 90 days).
7. those who had donated or lost 300 ml (or more) of blood within 3 months prior to the study.
8. those who smoked more than 10 cigarettes a day.
9. those who had a history of traveling to another city within the last 14 days
10. those with a history of direct contact with a COVID-19 positive person in the subject neighborhood
11. 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
12. those who were positive to COVID-19
13. those who were positive to HIV, HBsAg, and HCV tests (to be kept confidential).
14. those with a history of drug or alcohol abuse within 12 months prior to screening for this study.
15. those who were unlikely to comply with the protocol, e.g uncooperative attitude, inability to return for follow-up visits, poor venous access.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Suprax® 100 mg/5 mL dry syrup	Suprax 100 MG in 5 mL Oral Suspension	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.
Cefixime trihydrate 100 mg/5 mL dry syrup	Cefixime Trihydrate 100 mg/5 mL Dry Syrup	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.

Primary Outcome Measures

Name	Time	Method
Geometric Mean Ratio	32 hours	The ratio between test drug and reference drug
90% confidence intervals	32 hours	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.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics parameter	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	Area Under Curve from 0 to 32 hours (AUCt)

Trial Locations

Locations (1)

PT Pharma Metric Labs; 🇮🇩 Jakarta, DKI Jakarta, Indonesia