PROTOCOL AMENDMENT OF BIOEQUIVALENCE STUDY OF 100 MG DOXYCYCLINE HYCLATE (DOXICOR 100) CAPSULES PRODUCED BY PT. GENERO PHARMACEUTICALSIN COMPARISON WITH VIBRAMYCIN®100 MG CAPSULES MANUFACTURED BY PFIZER LABS, DIVISION OF PFIZER INC, USA

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT. Clinisindo Laboratories
No Registry
INA-EAXONFH
Tanggal Input Registry : 01-11-2024

06-06-2024
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.
 
PROTOCOL AMENDMENT OF BIOEQUIVALENCE STUDY OF 100 MG DOXYCYCLINE HYCLATE (DOXICOR 100) CAPSULES PRODUCED BY PT. GENERO PHARMACEUTICALSIN COMPARISON WITH VIBRAMYCIN®100 MG CAPSULES MANUFACTURED BY PFIZER LABS, DIVISION OF PFIZER INC, USA
PROTOCOL AMENDMENT OF BIOEQUIVALENCE STUDY OF 100 MG DOXYCYCLINE HYCLATE (DOXICOR 100) CAPSULES PRODUCED BY PT. GENERO PHARMACEUTICALSIN COMPARISON WITH VIBRAMYCIN®100 MG CAPSULES MANUFACTURED BY PFIZER LABS, DIVISION OF PFIZER INC, USA
Observational
Doxicor 100 (Doxycycline Hyclate 100 mg)
18
 

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, Have history or condition of severe/serious skin reactions, Have history or condition of esophageal lesions (esophagitis and ulcerations), Have history or condition of myasthenia gravis, Have history or condition of obstructive esophagic pathology, such as stenosis and achalasia, Have 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, 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.
 
No. S-155/UN2.F1/ETIK/PPM.00.02/2024
Not applicable
PPUK/PPUB number
BE24-23
apt. Andrea Elouise, S.Farm