Bioequivalence Study of Cefixime 100 mg Capsule Produced by PT. Pharma Laboratories in Comparison with Cefspan® (100 mg Cefixime) Capsule Manufactured by PT. Dankos Farma, for PT. Kalbe Farma Tbk., under License of Astellas Pharma Inc.

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT. Omega Medika Farma Laboratori
No Registry
INA-NLTZSWG
Tanggal Input Registry : 04-04-2023

01-12-2022
Primary Cmax (ng.mL-1) AUCt (h.ng.mL-1)
Secondary AUCinf (h.ng.mL-1) Tmax (h) T½ (h)
 
Bioequivalence Study of Cefixime 100 mg Capsule Produced by PT. Pharma Laboratories in Comparison with Cefspan® (100 mg Cefixime) Capsule Manufactured by PT. Dankos Farma, for PT. Kalbe Farma Tbk., under License of Astellas Pharma Inc.
Bioequivalence Study of Cefixime 100 mg Capsule Produced by PT. Pharma Laboratories in Comparison with Cefspan® (100 mg Cefixime) Capsule Manufactured by PT. Dankos Farma, for PT. Kalbe Farma Tbk., under License of Astellas Pharma Inc.
Interventional
NA
21
 

Inclusion Criteria:

 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 doctors' justification on the result of laboratory test include routine hematology, liver function, renal function, blood glucose, and urinalysis; history of disease, and physical examination).

Exclusion Criteria:

 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 10 sticks of cigarettes a day, - Have any bleeding or 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 below 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-1157/UN2.F1/ETIK/PPM.00.02/2022
117/RPT/OMF/2023
Utik Paraswati