Bioequivalence Study of Ciprofloxacin 500 mg Film-Coated Caplets (Interflox 500) Manufactured by PT. Interbat in Comparison with Ciproxine® 500 mg Film-Coated Tablets Manufactured by Bayer SA-NV (Machelen).

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT. Pharma Metric Labs
No Registry
INA-HWNSQBW
Tanggal Input Registry : 05-09-2023

10-02-2023
Cmax, AUC0-t
 
Bioequivalence Study of Ciprofloxacin 500 mg Film-Coated Caplets (Interflox 500) Manufactured by PT. Interbat in Comparison with Ciproxine® 500 mg Film-Coated Tablets Manufactured by Bayer SA-NV (Machelen).
Bioequivalence Study of Ciprofloxacin 500 mg Film-Coated Caplets (Interflox 500) Manufactured by PT. Interbat in Comparison with Ciproxine® 500 mg Film-Coated Tablets Manufactured by Bayer SA-NV (Machelen).
Interventional
Ciprofloxacin 500 mg Film-Coated Caplets (Interflox 500)
20
 

Inclusion Criteria:

Subjects had read the subject information and signed informed consent documents, Subjects age range from 18 – 55 years, Subjects’ body mass index between 18 – 25 kg/m2, Subjects had a normal electrocardiogram, Subjects had the blood pressure within normal range (systolic 90-120 mmHg and diastolic 60-80 mmHg), Subjects had the heart rate within normal range (60 – 100 bpm), Subjects had absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening, Subjects agreed to use protection (condom) before any intercourse with their spouse during the study

Exclusion Criteria:

those who were pregnant and/or nursing women (for women), those with history of contraindication or hypersensitivity to ciprofloxacin, or other fluoroquinolones, or other ingredients in the study products or a history of serious allergic reaction to any drug, a significant allergic disease, or allergic reaction, those with a history or presence of 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 cardiovascular disease, those with a history or presence of any coagulation disorder or clinically significant hematology abnormalities, those who were using any medication (prescription or non-prescription drug, food supplement, herbal medicine), particularly the medication known to affect the pharmacokinetic of the study drug, within one week prior to the drug administration day, those who had participated in any clinical study within 3 months prior to the study (
 
KET-1277/UN2.F1/ETIK/PPM.00.02/2022
Not applicable
PPUK/PPUB number
691/STD/PML/2022
Nabila Mudin S