Bioequivalence Study of Floxigra (Ciprofloxacin 500 mg) Film-Coated Caplets Manufactured by PT. Graha Farma in Comparison with Ciprobay® 500 mg Film-Coated Tablets Manufactured by Bayer AG, Germany, Registered by Bayer (South East Asia) Pte, Ltd, Singapore
Tahapan Penelitian : Complete
Sponsor:
PT. Graha Farma
Mitra Pelaksana:
PT. Pharma Metric Labs
No Registry
INA-6OYHFSL
Tanggal Input Registry : 14-11-2023
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 10-05-2023 |
| Outcome Primer | Cmax and AUCt |
| Outcome Skunder | |
| Descriptive Information | |
| Judul Penelitian Popular | Bioequivalence Study of Floxigra (Ciprofloxacin 500 mg) Film-Coated Caplets Manufactured by PT. Graha Farma in Comparison with Ciprobay® 500 mg Film-Coated Tablets Manufactured by Bayer AG, Germany, Registered by Bayer (South East Asia) Pte, Ltd, Singapore |
| Judul Penelitian Ilmiah | Bioequivalence Study of Floxigra (Ciprofloxacin 500 mg) Film-Coated Caplets Manufactured by PT. Graha Farma in Comparison with Ciprobay® 500 mg Film-Coated Tablets Manufactured by Bayer AG, Germany, Registered by Bayer (South East Asia) Pte, Ltd, Singapore |
| Jenis Penelitian | Interventional |
| Intervensi | Floxigra (Ciprofloxacin 500 mg) Film-Coated Caplets |
| Jumlah Subyek Penelitian | 14 |
| Recruitment Information | |
| Eligibility Criteria | 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 studyExclusion 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 ( |
| Administrative Information | |
| Nomor Persetujuan Etik | KET-10/UN2.F1/ETIK/PPM.00.02/2023 |
| Nomor Persetujuan Material Transfer Agreement | Not applicable |
| Nomor Persetujuan Pelaksanaan Uji Klinik | PPUK/PPUB number |
| Other Study ID Numbers | 690/STD/PML/2022 |
| Contact Person | Nabila Mudin Sutanto |