PROTOCOL AMENDMENT OF BIOEQUIVALENCE STUDY OF 500 MG VALACYCLOVIR (VALCOR) FILM COATED TABLETS PRODUCED BY PT. GENERO PHARMACEUTICALS IN COMPARISON WITH VALTREX 500 MG FILM COATED TABLETS MANUFACTURED BY GLAXO WELLCOME, S.A., SPAIN, IMPORTED BY PT. GLAXO WELLCOME INDONESIA
Tahapan Penelitian : Complete
Sponsor:
PT Genero Pharmaceuticals
Mitra Pelaksana:
PT Clinisindo Laboratories
No Registry
INA-DMY8NDO
Tanggal Input Registry : 10-11-2024
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 12-03-2024 |
| Outcome Primer | The primary objective of this study was to establish bioequivalence of 500 mg Valacyclovir (Valcor) film coated tablets produced by PT. Genero Pharmaceuticals in comparison with Valtrex 500 mg film coated tablets manufactured by Glaxo Wellcome, S.A., Spain, imported by PT. Glaxo Wellcome Indonesia |
| Outcome Skunder | |
| Descriptive Information | |
| Judul Penelitian Popular | PROTOCOL AMENDMENT OF BIOEQUIVALENCE STUDY OF 500 MG VALACYCLOVIR (VALCOR) FILM COATED TABLETS PRODUCED BY PT. GENERO PHARMACEUTICALS IN COMPARISON WITH VALTREX 500 MG FILM COATED TABLETS MANUFACTURED BY GLAXO WELLCOME, S.A., SPAIN, IMPORTED BY PT. GLAXO WELLCOME INDONESIA |
| Judul Penelitian Ilmiah | PROTOCOL AMENDMENT OF BIOEQUIVALENCE STUDY OF 500 MG VALACYCLOVIR (VALCOR) FILM COATED TABLETS PRODUCED BY PT. GENERO PHARMACEUTICALS IN COMPARISON WITH VALTREX 500 MG FILM COATED TABLETS MANUFACTURED BY GLAXO WELLCOME, S.A., SPAIN, IMPORTED BY PT. GLAXO WELLCOME INDONESIA |
| Jenis Penelitian | Observational |
| Intervensi | |
| Jumlah Subyek Penelitian | 24 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: Subjects must satisfy the following criteria to be enrolled in the study: Give 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 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 (will be done for female subjects at screening, before period I and before period II of the study), Subject has either received COVID-19 (Coronavirus) vaccine minimum of first booster or negative result for rapid antigen test of COVID-19 at screening. Note:* The clinical investigator may include a subject having value outside the accepted range, if in his/her opinion, these values are not clinically significant.Exclusion Criteria: Subjects will be excluded if the following reasons exist: Smoker. If necessary, light smoker (≤5 cigarettes/day) can be accepted, Pregnant women or nursing mother, Have history of hepatic, cardiovascular, gastrointestinal or renal disease, Hypersensitivity to valacyclovir, acyclovir 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, Have 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-720/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 | BE14-23 Version 2 |
| Contact Person | apt. Andrea Elouise, S.Farm |