Bioequivalence Study of 500 mg Ciprofloxacin Film Coated Tablet Produced by PT. Hexpharm Jaya in comparison with 500 mg Ciproxin Film Coated Tablet Produced by PT. Bayer Indonesia

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT Pharma Metric Labs
No Registry
INA-S6DZ56G
Tanggal Input Registry : 10-08-2023

17-12-2011
Cmax, AUC0-t
 
Bioequivalence Study of 500 mg Ciprofloxacin Film Coated Tablet Produced by PT. Hexpharm Jaya in comparison with 500 mg Ciproxin Film Coated Tablet Produced by PT. Bayer Indonesia
Bioequivalence Study of 500 mg Ciprofloxacin Film Coated Tablet Produced by PT. Hexpharm Jaya in comparison with 500 mg Ciproxin Film Coated Tablet Produced by PT. Bayer Indonesia
Interventional
Ciprofloxacin 500 mg film coated tablet
20
 

Inclusion Criteria:

Healthy male or female subject with absense of significant disease or cliniccally significantabnormal laboratory values on laboratory evaluation, medical history or physical examination during screening, age 18 - 55 years, body mass index between 18-23 kg.m2, have read the subject information and signed informed consent documents.

Exclusion Criteria:

Those who were pregnant (confirmed by pregnancy test on study day jus before taking the study drug) and or nursing woman, those with history of hypersensitivity to fluoroquinolone drugs or a history of serious allergic reaction to any drug, significant allergic disease, allergic reaction or active allergic, those with history or present medical condition which might significantly influence the pharmacokinetic of the study drug, e.g. chronic gastrointestinal disease, diarrhea, gastric surgery, renal insufficiency, hepatic dysfunction, or candiovascular disease, those with history or presence of any coagulation disorser or clinically significant hematology abnormalities, who were using any medication (prescription or non prescription drug, food supplement, herbal medicine) particularly the medication known to affect the pharmacokinetic of study drug within 7 days prior to the dosing day, those who have participated in any clinical study within 3 months prior to the study, those who have donated or lost 300 mL (or more) of blood within 3 months prior to the study, those who smoked cigarettes, thos who were positive to HIV,HBsAg, and HCV test, those with history of drug or alcohol abuse within 12 months prior to screening for this study, those who are unlikely to comply with the protocol, e.g uncooperative attitude, inability to complete the study schedule, poor venous access.
 
Nomor : 24/PT02.FK/ETIK/2010
Not applicable
PPUK/PPUB number
Nabila Mudin S