Bioequivalence Study of Ciprofloxacin 500 mg Film-Coated Caplets (Samquinor® 500 mg) Manufactured by PT Samco Farma in Comparison with Ciprobay® 500 mg Film-Coated Tablets Manufactured by Bayer Co. (Malaysia) Sdn Bhd, Malaysia

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT Pharma Metric Labs
No Registry
INA-NCZDPMR
Tanggal Input Registry : 08-05-2024

10-08-2023
Cmax, AUCt
 
Bioequivalence Study of Ciprofloxacin 500 mg Film-Coated Caplets (Samquinor® 500 mg) Manufactured by PT Samco Farma in Comparison with Ciprobay® 500 mg Film-Coated Tablets Manufactured by Bayer Co. (Malaysia) Sdn Bhd, Malaysia
Bioequivalence Study of Ciprofloxacin 500 mg Film-Coated Caplets (Samquinor® 500 mg) Manufactured by PT Samco Farma in Comparison with Ciprobay® 500 mg Film-Coated Tablets Manufactured by Bayer Co. (Malaysia) Sdn Bhd, Malaysia
Interventional
Samquinor® 500 mg film-coated caplets
14
 

Inclusion Criteria:

Subjects had read the subject information and able to give written informed consent for participation in the study and complied with the study protocol/procedures, Subjects healthy male and female, Subjects age range from 18 – 55 years, Subjects’ body mass index between 18 – 25 kg/m2, Subjects had a normal electrocardiogram, Subjects had the resting vital signs (after 10 – 15 minutes of resting) were within the following ranges, Systolic blood pressure: 90 – 129 mmHg, Diastolic blood pressure: 60 – 84 mmHg, Pulse/Heart rate: 60 – 100 beats per minute, Subjects had no significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening

Exclusion Criteria:

Those who were pregnant and/or nursing women (for women), Those with history of contraindication or hypersensitivity to ciprofloxacin, or allied drugs, 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 disagreed to use non-hormonal contraceptives methods (condom) before any intercourse with their spouse throughout study period, 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-766/UN2.F1/ETIK/PPM.00.02/2023
Not applicable
PPUK/PPUB number
713/STD/PML/2023
Nabila Mudin S