Bioequivalence Study of Valsartan 160 mg Film-Coated Tablets (Valmarox FCT 160 mg) Manufactured by PT Amarox Pharma Global in Comparison with Diovan® 160 mg Film-Coated Tablets Manufactured by Siegfried Barberá Sl., Barberá del Vallés, Barcelona, Spain for Novartis Pharma AG, Basel, Switzerland, Imported by PT Novartis Indonesia, Jakarta, Indonesia in Healthy Subjects under Fasting Condition.

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT. Pharma Metric Labs
No Registry
INA-6ZKTB4NH
Tanggal Input Registry : 27-03-2025

02-01-2025
Cmax, AUCt
 
Bioequivalence Study of Valsartan 160 mg Film-Coated Tablets (Valmarox FCT 160 mg) Manufactured by PT Amarox Pharma Global in Comparison with Diovan® 160 mg Film-Coated Tablets Manufactured by Siegfried Barberá Sl., Barberá del Vallés, Barcelona, Spain for Novartis Pharma AG, Basel, Switzerland, Imported by PT Novartis Indonesia, Jakarta, Indonesia in Healthy Subjects under Fasting Condition.
Bioequivalence Study of Valsartan 160 mg Film-Coated Tablets (Valmarox FCT 160 mg) Manufactured by PT Amarox Pharma Global in Comparison with Diovan® 160 mg Film-Coated Tablets Manufactured by Siegfried Barberá Sl., Barberá del Vallés, Barcelona, Spain for Novartis Pharma AG, Basel, Switzerland, Imported by PT Novartis Indonesia, Jakarta, Indonesia in Healthy Subjects under Fasting Condition.
Interventional
Valmarox FCT 160 mg
33
 

Inclusion Criteria:

Subjects had read the subject information and were able to give written informed consent for participation in the study and comply with the study protocol/procedures, Subjects were 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 ranges: Systolic blood pressure: 100 – 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 valsartan or allied drugs, or other ingredients in the study products, or a history of serious allergic reaction to any drug, 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/intestine surgery, renal insufficiency, hepatic dysfunction or any cardiovascular disease, those who had history or presence of any coagulation disorder or clinically significant hematology abnormalities, those who disagreed to use non-hormonal contraceptives methods (condom) before any intercourse with their spouse within study period (from subject screening until 1 week after the last drug administration), those who were 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 habits with more than 10 cigarettes a day those with a history or present of sore throat, fever (with temperature more than 37°C), cough, cold, anosmia/loss of smell, or dyspnea with in the last 14 days, those who were positive result for HIV, HbsAg, and HCV tests (to be kept confidential), those were 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-1656/UN2.F1/ETIK/PPM.00.02/2024
Not applicable
PPUK/PPUB number
872/STD/PML/2024
Nabila Mudin S