Bioequivalence Study of Cefixime Trihydrate Dry Syrup in Indonesia Healthy Volunteers

• Status: Completed
• Trial end date: 2020-08-25
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: PT Bernofarm
• Collaborator: PT Pharma Metric Labs
• Treatments: Cefixime

Criteria

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.