Bioequivalence study of cefixime 100 mg/5 mL dry syrup produced by PT IFARS Pharmaceutical Laboratories (Helixim® Dry Syrup) in comparison with the comparator drug (Cefspan® 100mg/5mL Dry Syrup, produced by PT Dankos Farma, for PT Kalbe Farma Tbk., Indonesia, under license of Otsuka Chemical Co., Ltd., Japan) when administered under fasting condition in healthy subjects

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT Equilab International
No Registry
INA-98KL19S
Tanggal Input Registry : 06-06-2024

05-03-2024
AUC0-t dan Cmax
 
Bioequivalence study of cefixime 100 mg/5 mL dry syrup produced by PT IFARS Pharmaceutical Laboratories (Helixim® Dry Syrup) in comparison with the comparator drug (Cefspan® 100mg/5mL Dry Syrup, produced by PT Dankos Farma, for PT Kalbe Farma Tbk., Indonesia, under license of Otsuka Chemical Co., Ltd., Japan) when administered under fasting condition in healthy subjects
Bioequivalence study of cefixime 100 mg/5 mL dry syrup produced by PT IFARS Pharmaceutical Laboratories (Helixim® Dry Syrup) in comparison with the comparator drug (Cefspan® 100mg/5mL Dry Syrup, produced by PT Dankos Farma, for PT Kalbe Farma Tbk., Indonesia, under license of Otsuka Chemical Co., Ltd., Japan) when administered under fasting condition in healthy subjects
Interventional
The participating subjects were required to have an overnight fast and in the next morning (first day of each period) were given orally one of test drug (cefixime 100 mg/5 mL dry syrup produced by PT IFARS Pharmaceutical Laboratories) or one of comparator drug (Cefspan® 100mg/5mL Dry Syrup, produced by PT Dankos Farma, for PT Kalbe Farma Tbk., Indonesia, under license of Otsuka Chemical Co., Ltd., Japan).
24
 

Inclusion Criteria:

1. Able to participate, communicate well with the investigators and would provide written informed consent to participate in the study, 2. Healthy male and female subjects with absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening and could be considered healthy based on the evaluation, 3. Aged 18 – 55 years inclusive, 4. Preferably non-smokers or smoke less than 10 cigarettes each day, 5. Body mass index within 18 to 25 kg/m2, 6. Vital signs (after 10 minutes rest) were within the following ranges: -Systolic blood pressure: 100 – 129 mmHg, -Diastolic blood pressure: 60 – 84 mmHg, -Pulse rate: 60 – 90 bpm, 7. Willing to practice abstention or non-hormonal contraception during the study, 8. History at least one booster COVID-19 vaccination or negative result in COVID 19 antigen rapid test at screening and during check-in

Exclusion Criteria:

1. History of allergy or hypersensitivity or contraindication to cefixime or allied drugs, 2. Pregnant or lactating female (urinary pregnancy test will be applied to female subjects at screening and before taking the drug study), 3. Any major illness in the past 90 days or clinically significant ongoing chronic medical illness, 4. Presence of any clinically significant abnormal values during screening e.g. significant abnormality of liver function test (AST, ALT, alkaline phosphatase, total bilirubin, direct bilirubin ≥ 1.5 ULN), renal function test (serum creatinine concentration > 1.4 mg/dL and ureum ≥ 1.5 ULN), etc, 5. Positive Hepatitis B surface antigen (HBsAg), anti-HCV, or anti-HIV, 6. Clinically significant hematology abnormalities, 7. Clinically significant electrocardiogram (ECG) abnormalities, 8. Any surgical or medical condition (present or history) which might significantly alter the absorption, distribution, metabolism or excretion of the study drug, e.g. gastrointestinal disease including gastric or duodenal ulcers or history of gastric surgery, 9. Past history of anaphylaxis or angioedema, 10. History of drug or alcohol abuse within 12 months prior to screening for this study, 11. Participation in any clinical trial within the past 90 days calculated from the last visit to this study’s first dosing day, 12. History of any bleeding or coagulative disorders, 13. Presence of difficulty in accessibility of veins in left or right arm during screening, 14. A donation or significant blood loss within 90 days before this study’s first dosing day, 15. Intake of any prescription drug (especially cefixime or ofloxacin), non prescription drug (including hormonal contraception), food supplements or herbal medicines within 21 days of this study’s first dosing day
 
S-68/UN2.F1/ETIK/PPM.00.02/2024
Not applicable
PPUK/PPUB number
BE. 806/EQL/2023
Ronal Simanjuntak – PT Equilab International