PROTOCOL AMENDMENT OF BIOEQUIVALENCE STUDY OF 100 MG DOXYCYCLINE HYCLATE (DOXICOR 100) CAPSULES PRODUCED BY PT. GENERO PHARMACEUTICALS IN COMPARISON WITH VIBRAMYCIN® 100 MG CAPSULES MANUFACTURED BY PFIZER LABS, DIVISION OF PFIZER INC, USA
Tahapan Penelitian : Complete
Sponsor:
PT Genero Pharmaceuticals
Mitra Pelaksana:
PT. Clinisindo Laboratories
No Registry
INA-K6O8786
Tanggal Input Registry : 01-11-2024
Tracking Information | |
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Tanggal Antisipasi Studi | 06-06-2024 |
Outcome Primer | The primary objective of this study was to establish bioequivalence of 100 mg Doxycycline Hyclate (Doxicor 100) capsules produced by PT. Genero Pharmaceuticals in comparison with Vibramycin® 100 mg capsules manufactured by Pfizer Labs, Division of Pfizer Inc, USA |
Outcome Skunder | |
Descriptive Information | |
Judul Penelitian Popular | PROTOCOL AMENDMENT OF BIOEQUIVALENCE STUDY OF 100 MG DOXYCYCLINE HYCLATE (DOXICOR 100) CAPSULES PRODUCED BY PT. GENERO PHARMACEUTICALS IN COMPARISON WITH VIBRAMYCIN® 100 MG CAPSULES MANUFACTURED BY PFIZER LABS, DIVISION OF PFIZER INC, USA |
Judul Penelitian Ilmiah | PROTOCOL AMENDMENT OF BIOEQUIVALENCE STUDY OF 100 MG DOXYCYCLINE HYCLATE (DOXICOR 100) CAPSULES PRODUCED BY PT. GENERO PHARMACEUTICALS IN COMPARISON WITH VIBRAMYCIN® 100 MG CAPSULES MANUFACTURED BY PFIZER LABS, DIVISION OF PFIZER INC, USA |
Jenis Penelitian | Observational |
Intervensi | |
Jumlah Subyek Penelitian | 18 |
Recruitment Information | |
Eligibility Criteria | Inclusion Criteria: Subjects must satisfied the following criteria to be enrolled in the study: Gave a written informed consent, Healthy subjects, both sexes, age between 18 to 55 years old, Weight with the normal range according to accepted normal values for the Body Mass Index (BMI = 18-25 kg/m2), Accepted normal values of blood pressure (systolic blood pressure 90 mmHg, diastolic blood pressure 60 mmHg) and heart rate (60-90 bpm)*, Acceptable medical history and physical examination, Normal hematology values including: hemoglobin, hematocrit, erythrocyte, leukocyte, mean corpuscular (MC) values, leukocyte differential, platelets count and erythrocyte sedimentation rate (ESR)*, Normal laboratory tests including: sGPT, sGOT, alkaline phosphatase, total bilirubin, total protein, albumin, globulin, blood glucose, blood urea nitrogen, ureum, creatinine*, Normal urinalysis results including: color, clarity, specific gravity, pH, leukocyte esterase, nitrite, glucose, keton, urobilinogen, bilirubin, blood and urine sediments (cells, casts, and bacteria)*, Normal cardiovascular function was proven by electrocardiogram (ECG) result, Negative result for serological tests of hepatitis B antigen (HBsAg), Hepatitis C (anti HCV), HIV (anti HIV), Negative result for drug of abuse tests of amphetamine, metamphetamine, morphine, marijuana/ tetrahydrocannabinol (THC), and benzodiazepine, Negative result for pregnancy test (was done for female subjects at screening, before period I and before period II of the study), Subject had either received COVID-19 (Coronavirus) vaccine minimum of first booster or negative result for COVID-19 rapid antigen test at screening. Note:* The clinical investigator might include a subject having value outside the accepted range, if in his/her opinion, these values were not clinically significant.Exclusion Criteria: Subjects would be excluded if the following reasons existed: Smoker. If necessary, light smoker (≤5 cigarettes/day) could be accepted, Pregnant women or nursing mother, Had history of hepatic, cardiovascular, gastrointestinal or renal disease, Had history or condition of severe/serious skin reactions, Had history or condition of esophageal lesions (esophagitis and ulcerations), Had history or condition of myasthenia gravis, Had history or condition of obstructive esophagic pathology, such as stenosis and achalasia, Had history or condition of autoimmune reactions or disease, Hypersensitivity to doxycycline, tetracycline antibiotics, or similar medication, History of alcohol, drug abuse within 12 months prior to screening for this study, Received any other medications within fourteen days prior to the start of the study, Participated in any clinical study within 3 months after the date of completion, Donation or loss more than 300 mL of blood within 3 months prior to the screening of the study, Had symptoms related to COVID-19 (e.g. fever, cough, cold, sore throat, or anosmia) or close contact with COVID-19 patients within fourteen days prior to the start of the study. |
Administrative Information | |
Nomor Persetujuan Etik | No. S-155/UN2.F1/ETIK/PPM.00.02/2024 |
Nomor Persetujuan Material Transfer Agreement | Not applicable |
Nomor Persetujuan Pelaksanaan Uji Klinik | PPUK/PPUB number |
Other Study ID Numbers | BE24-23 |
Contact Person | apt. Andrea Elouise, S.Farm |