Bioequivalence Study of Atenolol 50 mg Tablet (Internolol® 50 Tablet) Manufactured by PT Interbat in Comparison with Tenormin® 50 mg Film-Coated Tablet Manufactured by Astrazeneca AB, Swedia

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT. Pharma Metric Labs
No Registry
INA-NZ052EP
Tanggal Input Registry : 01-03-2024

20-12-2023
Cmax, AUCt
 
Bioequivalence Study of Atenolol 50 mg Tablet (Internolol® 50 Tablet) Manufactured by PT Interbat in Comparison with Tenormin® 50 mg Film-Coated Tablet Manufactured by Astrazeneca AB, Swedia
Bioequivalence Study of Atenolol 50 mg Tablet (Internolol® 50 Tablet) Manufactured by PT Interbat in Comparison with Tenormin® 50 mg Film-Coated Tablet Manufactured by Astrazeneca AB, Swedia
Interventional
Internolol® 50 mg tablet batch no ZT0287202 (Formula A) and Internolol® 50 mg tablet batch no ZT0287203 (Formula B)
24
 

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, Subjects healthy male and female, Subjects’ age ranges 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: 110 – 129 mmHg, Diastolic blood pressure: 70 – 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 who were pregnant and/or nursing condition,those with a history of hypersensitivity or contraindication to atenolol, 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 who had history or presence of any coagulation disorder or clinically significant hematology abnormalities, those who had history or presence of any metabolic acidosis condition those who had history or presence of asthma or chronic obstructive pulmonary disease or other health problems with symptoms of difficulty breathing, those who disagree to use non-hormonal contraceptives methods (condom) before any intercourse with their spouse throughout study period 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 had participated in any clinical study within the past 90 days prior to the study, those who had donated or lost 300 mL (or more) of blood within 3 months prior to the study, those who had smoking habit with more than 10 cigarettes a day, those who not receiving the complete primary SARS CoV-2 vaccine, those who were positive result of SARS CoV-2 antigen test (for those who has not received the first booster vaccine), those with history of direct contact with a COVID-19 positive person in the subject’s neighborhood within the last 14 days, those who with 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 positive result for HIV, HbsAg, and HCV tests (to be kept confidential), those who had 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-1308/UN2.F1/ETIK/PPM.00.02/2023
Not applicable
PPUK/PPUB number
739/STD/PML/2023
Nabila Mudin S