Bioequivalence Study of Cefixime Trihydrate Dry Syrup in Indonesia Healthy Volunteers

Drug Use Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04982861
• Other study ID #: 432/STD/PML/2018
• Status: Completed
• Phase: N/A
• Start date: June 15, 2020
• Est. completion date: August 25, 2020

Study information

• Verified date: August 2021
• Source: PT Bernofarm
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: August 25, 2020
• Est. primary completion date: August 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Drug Use

Intervention

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
• Suprax 100 MG in 5 mL Oral Suspension
Participants received a single dose of 5 mL of Suprax with 240 mL of water

Locations

Country	Name	City	State
Indonesia	PT Pharma Metric Labs	Jakarta	DKI Jakarta

Sponsors (2)

Lead Sponsor	Collaborator
PT Bernofarm	PT Pharma Metric Labs

Country where clinical trial is conducted

Indonesia, 

References & Publications (3)

Asiri YA, Al-Said MS, Al-Khamis KI, Niazy EM, El-Sayed YM, Al-Rashood KA, Al-Yamani MJ, Alsarra IA, Al-Balla SA. Comparative bioavailability study of cefixime (equivalent to 100 mg/5 ml) suspension (Winex vs Suprax) in healthy male volunteers. Int J Clin Pharmacol Ther. 2005 Oct;43(10):499-504. — View Citation

Kees F, Naber KG, Sigl G, Ungethüm W, Grobecker H. Relative bioavailability of three cefixime formulations. Arzneimittelforschung. 1990 Mar;40(3):293-7. — View Citation

Morais JA, Lobato Mdo R. The new European Medicines Agency guideline on the investigation of bioequivalence. Basic Clin Pharmacol Toxicol. 2010 Mar;106(3):221-5. doi: 10.1111/j.1742-7843.2009.00518.x. Epub 2010 Jan 7. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Geometric Mean Ratio	The ratio between test drug and reference drug	32 hours
Primary	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	Pharmacokinetics parameter	Maximum plasma concentration (Cmax)	32 hours
Secondary	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

External Links

•   Bioavailability and Bioequivalence Studies for Orally Administered Drug Products - General Considerations
•   Clinical Pharmacology and Biopharmaceutic Review
•   Guideline For Good Clinical Practice