Bioequivalence study of Fixacep (100 mg/5 mL Cefixime) dry syrup produced by PT Pratapa Nirmala in comparison with Cefspan (100 mg/5 mL Cefixime) dry syrup produced by PT Dankos Farma for PT Kalbe Farma Tbk., under license of Astellas Pharma Inc.

Tahapan Penelitian : Rampung
Sponsor:
Mitra Pelaksana:
PT. Omega Medika Farma Laboratori
No Registry
INA-YGL0K5S
Tanggal Input Registry : 18-08-2022

28-06-2022
AUC0-t dan Cmax
AUC0-∞, t1/2, dan tmax
 
Bioequivalence study of Fixacep (100 mg/5 mL Cefixime) dry syrup produced by PT Pratapa Nirmala in comparison with Cefspan (100 mg/5 mL Cefixime) dry syrup produced by PT Dankos Farma for PT Kalbe Farma Tbk., under license of Astellas Pharma Inc.
Bioequivalence study of Fixacep (100 mg/5 mL Cefixime) dry syrup produced by PT Pratapa Nirmala in comparison with Cefspan (100 mg/5 mL Cefixime) dry syrup produced by PT Dankos Farma for PT Kalbe Farma Tbk., under license of Astellas Pharma Inc.
Eksperimental
The reference drug was the market available Cefspan® (100 mg/5 mL Cefixime) dry syrup produced by PT Dankos Farma for PT Kalbe Farma Tbk., under license of Astellas Pharma Inc, batch number DCEFA00192; manufacturing date on July 2020; expiration date on July 2022. The test drug was Fixacep (100 mg/5 mL Cefixime) dry syrup produced by PT Pratapa Nirmala, batch number 8AB005; manufacturing date on February 2022; expiration date on February 2024. Subjects took one dose of Cefixime products of either formulation (reference or test), as per randomization scheme with 240 ml of water in sitting position.
22
 

Inclusion Criteria:

- Willing to sign the informed consent. - Age 18 – 55 years, - Body mass index between 18 – 25 kg/m2 - Normotensive (systolic blood pressure 100 – 120 mmHg, diastolic blood pressure 60-80 mmHg), heart rate 60 – 90 beats per minute, - Healthy male (healthy criteria is determined by normal values or if outside the normal range of values but no clinically significant effects based on doctor’s justification on the result of laboratory test include routine hematology, liver function, renal function, blood sugar and urinalysis; history of disease, and physical examination).

Exclusion Criteria:

- Contraindicated and/or has history of hypersensitivity to Cefixime or related drug - With 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 or cardiovascular disease, - Using any medication (prescription or non-prescription drug, food supplement, herbal medicine) within 7 days prior to the dosing day. - Participated in any clinical study within 3 months prior the study. - Donated or lost 300 mL (or more) of blood within 3 months prior the study, - Smoke more than 9 sticks of cigarettes a day, - Have any bleeding or blood coagulation disorder, - Indicate the positive result on test for HbsAg, Anti-HCV and anti-HIV. - With the history of alcohol and drug abuse - If the study is conducted in Covid-19 pandemic situation, the exclusions criteria bellow must be applied: a. With history of direct contact with a Covid-19 positive person within last 14 days, b. With history or present sore throat, fever (temperature more than 37oC) or short of breath within last 14 days, c. Positive to Covid-19 antigen rapid test.
 
KET-501/UN2.F1/ETIK/PPM.00.02/2022
NA
RG.01.02.321.06.22.00951/UB
153/FORM/OMF/2022
apt. Haranissa Dea Oktania