Bioequivalence Study of 100 mg/5 mL Cefixime Dry Syrup, Manufactured by PT. Pharos Indonesia (Fixiphar®) in Comparison with the Innovator’s Dry Suspension (Suprax®), Manufactured by Odan Laboratories Ltd., Montreal

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
1. Committe Ethic From Faculty of medicine Indonesian University 2. Badan Pengawas Obat dan Makanan Republik Indonesia (BPOM RI)
No Registry
INA-R19L03X
Tanggal Input Registry : 10-08-2023

23-02-2022
AUC0-t and Cmax
 
Bioequivalence Study of 100 mg/5 mL Cefixime Dry Syrup, Manufactured by PT. Pharos Indonesia (Fixiphar®) in Comparison with the Innovator’s Dry Suspension (Suprax®), Manufactured by Odan Laboratories Ltd., Montreal
Bioequivalence Study of 100 mg/5 mL Cefixime Dry Syrup, Manufactured by PT. Pharos Indonesia (Fixiphar®) in Comparison with the Innovator’s Dry Suspension (Suprax®), Manufactured by Odan Laboratories Ltd., Montreal
Interventional
Subject would be fasted during 10 hours and the next morning, physician instructed subjects to consume 10 mL dry syrup of test product or 10 mL dry suspension product with 240 mL of water or equivalent to a glass of mineral water. The drugs was given with catheter tip, before given to subjects, test or reference drug was mixed completely, then washing the catheter tip. Subjct would be instructed to kept sitting or laying on their back rigt after dosing until four (4) hours after dosing.
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Inclusion Criteria:

Able to participate, communicate well with the investigators and agree to sign an informed consent, Willing to use contraception (condoms) when intercourse with spouse during the study, Healthy male/female subjects as determined by the medical screening assessments, Aged 18-55 years of age, Body mass index (BMI) is in the range of 18-25 kg/m², Normal blood pressure (systolic 100-120 mmHg; diastolic 60-80 mmHg), Normal pulse rate 60-90 bpm, Normal electrocardiogram (ECG), Clinical laboratory results have to be within normal range. Medical judgement of responsible physician determined any laboratory finding beyond its standard value.

Exclusion Criteria:

Pregnant or lactating women (urinary pregnancy test to be applied to female subjects when screening and just before taking the test or innovator drug), Known hypersensitivity or contraindication to the study drug; intake of any prescription drug or non-prescription drug/food supplement/herbal medicine within 7 days of this study’s first dosing day, History of any prior allergic drug rash, History of any bleeding or coagulation disorders, Any surgical or medical condition (present or history) which might significantly alters the absorption, distribution, metabolism or excretion of the study drug, e.g. gastrointestinal diseases including gastric or duodenal ulcers or history of gastric surgery, A donation or loss of 300 mL (or more) of blood within 3 months before this study’s first dosing day, A positive Hepatitis B surface antigen (HBsAg), HCV, HIV test result, History of drug or alcohol abuse within 12 months prior to this study; Heavy Smoker (more than 10 cigarettes a day), Clinically have significant bleeding within 3 months prior to the study, Participation in a previous study within 3 months of this study’s first dosing day, A positive nasopharyngeal swab SARS-CoV2 (Covid-19) antigen rapid test result. Covid-19 antigen rapid test to be applied to all subjects when screening and one day before drug administration in each period of study.
 
KET-189/UN2.F1/ETIK/PPM.00.02/2020
MTA number
PPUK/PPUB number
Ni Made Dwi Wulandari, S.KM.