Bioequivalence Study of Tamsulosin Hydrochloride 0.4 mg Sustained-Release Film-Coated Tablet (Tamiva® SR) Manufactured by PT Interbat in Comparison with Harnal® OCAS 0.4 mg Film-Coated Prolonged Released Tablet Manufactured by Astellas Pharma Europe B.V, The Netherlands, Imported by PT Combiphar, Indonesia.

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT Pharma Metric Labs
No Registry
INA-T62XR1K
Tanggal Input Registry : 22-03-2024

25-08-2023
Cmax, AUCt
 
Bioequivalence Study of Tamsulosin Hydrochloride 0.4 mg Sustained-Release Film-Coated Tablet (Tamiva® SR) Manufactured by PT Interbat in Comparison with Harnal® OCAS 0.4 mg Film-Coated Prolonged Released Tablet Manufactured by Astellas Pharma Europe B.V, The Netherlands, Imported by PT Combiphar, Indonesia.
Bioequivalence Study of Tamsulosin Hydrochloride 0.4 mg Sustained-Release Film-Coated Tablet (Tamiva® SR) Manufactured by PT Interbat in Comparison with Harnal® OCAS 0.4 mg Film-Coated Prolonged Released Tablet Manufactured by Astellas Pharma Europe B.V, The Netherlands, Imported by PT Combiphar, Indonesia.
Interventional
Tamiva® SR 0.4 mg film-coated tablet
60
 

Inclusion Criteria:

Subjects had read the subject information and able to give written informed consent for participation in the study and comply with the study protocol/procedures, Healthy male subjects, Subjects age range from 18 – 55 years, Subjects’ body mass index between 18 – 25 kg/m2, Subjects had a normal electrocardiogram, Subjects had resting vital signs (after 10 – 15 minutes of resting) were within the following range 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 with a history of hypersensitivity or contraindication to tamsulosin 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 pharmacokinetics 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 had history of orthostatic hypotension, those with had presence of cataract or glaucoma, those who using any medication (prescription or non-prescription drug, food supplement, herbal medicine), particularly the medication known to affect the pharmacokinetics of the study drug, within one week prior to the drug administration day, those who participated in any clinical study within the past 90 days prior to the study, those who had participated in any clinical study within 3 months prior to the study (< 90 days), those who had donated or lost 300 mL (or more) of blood within 3 months prior to the study, those who were smoker those with a history of direct contact with a COVID-19 positive person in the subject’s neighborhood those with a history or present of sore throat, fever (with temperature more than 37°C), cough, cold, anosmia/loss of smell, or dyspnea within the last 14 days, those who were positive to SARS CoV-2 antigen test, those who were positive to HIV, HBsAg, and HCV tests (to be kept confidential), those with a history of drug or alcohol abuse within 12 months prior to screening for this study, those who were unlikely to comply with the protocol, e.g. uncooperative attitude, inability to return for follow up visits, poor venous access.
 
KET-763/UN2.F1/ETIK/PPM.00.02/2023
Not applicable
PPUK/PPUB number
Nabila Mudin S