Healthy male and female subjects Healthy volunteers, Bioequivalence, Sacubitril/Valsartan 200 mg tablets Fasting
Conditions
Interventions
Each tablet contains 97.2 mg of sacubitril and 102.8 mg of valsartan as sodium salt complex.,Each tablet contains 97.2 mg of sacubitril and 102.8 mg of valsartan as sodium salt c
Experimental Drug,Active Comparator Drug
SAVATO 200 (Sacubitril/Valsartan 200 mg tablets),Entresto (Sacubitril/Valsartan 200 mg tablets)
Sponsors
Dr.porranee puranajoti
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1) Non-smokers, normal, healthy, adult, both males and females subjects between 18 and 55 years of age (both inclusive). 2) Having a Body Mass Index (BMI) between 18.5 and 30.0 (both inclusive), calculated as weight in kg/height in m2. 3) Subject whose clinical laboratory values are within normal/acceptable reference ranges or clinically insignificant during screening as determined by physician or principal investigator to be of no clinical significance. If any subject has values outside of the pre-defined normal/acceptable range, the study physician/ Principal Investigator should have a clearly documented and medically rigorous justification for making that exception. 4) Subject whose medical history, clinical examination, 12 lead ECG, and chest X-ray recordings (postero-anterior view) are normal or clinically insignificant during screening as determined by physician or principal investigator to be of no clinical significance. 5) Able to understand and comply with the study procedures, in the opinion of the investigator. 6) Able to give voluntary written informed consent for participation in the trial. 7) In case of female subjects: 7.1 Surgically sterilized at least 06 months prior to study participation; Or 7.2 If of child bearing potential is willing to use a suitable and effective double barrier contraceptive method or intra uterine device during the study. And 7.3 Urine pregnancy test must be negative.
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity to sacubitril or valsartan or any excipients or any related drug or any substance. 2. History or presence of any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system. 3. Subjects who are being or have previously been treated for any gastrointestinal problems or convulsive, depressive or hepatic disorders, and in whom there is a risk of a recurrence during the study period. 4. Ingestion or use of any prescribed medication and over the counter medication including herbal remedies and St John Wort within 14 days prior to dosing in period I. In any such case subject selection will be at the discretion of the Principal Investigator. 5. Any history of bronchospasm, asthma, urticaria or other allergic type reactions after taking any medication. 6. Consumption of grapefruits and grapefruit products within 72 hours prior to dosing in period-I. 7. Consumption of xanthine containing food or beverages such as tea, coffee, chocolates or cola drinks and tobacco or tobacco containing products within 24 hours prior to IMP administration in period I. 8. Smokers or subjects who have smoked within the last 6 months prior to the start of the study. 9. A recent history of harmful use of alcohol less than 2 years. This means alcohol consumption of more than 14 standard drinks per week for men and more than 7 standard drinks per week for women. A standard drink is defined as 360 milliliters of beer or 150 milliliters of wine or 45 milliliters of distilled spirits such as rum, whisky or brandy. Also exclusion applies if alcohol was consumed within 48 hours prior to dosing in period I. 10. Presence of clinically significant abnormal laboratory values during screening. 11. Use of any recreational drugs or history of drug addiction or testing positive in pre study drug scans. 12. History or presence of seizure or psychiatric disorder. 13. History of difficulty with donating blood. 14. Difficulty in swallowing solid dosage forms such as tablets or capsules. 15. Donation of blood one unit or 350 milliliters within 90 days prior to the first dose of study medication. 16. Receipt of an investigational medicinal product or participation in a drug research study within 90 days prior to the first dose of study medication. If an investigational medicinal product was received within 90 days where there was no blood loss except safety laboratory testing, the subject may be included considering a duration equivalent to 10 half lives of the investigational product received. 17. Positive hepatitis screening including hepatitis B surface antigen and or HCV antibodies. 18. Positive test result for HIV antibody type 1 and or type 2. 19. Unusual diet for any reason for example fasting, high potassium diet or low sodium diet within 4 weeks prior to receiving the study drug in period I. In such cases subject selection will be at the discretion of the Principal Investigator. 20. Nursing mothers female subjects. 21. Sitting blood pressure less than 110 over 70 millimeters of mercury or pulse rate less than 60 or more than 100 beats per minute.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters (Cmax, AUC0-t, AUC0-inf) of sacubitril and valsartan following a single oral dose under fasting conditions Pre-dose and up to 36 hours post-dose. Plasma drug concentration determined by validated LC-MS/MS method | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters (Cmax, AUC0-t, AUC0-inf) of sacubitril and valsartan following a single oral dose under fasting conditions Pre-dose and up to 36 hours post-dose Plasma drug concentration determined by validated LC-MS/MS method,Safety parameters Screening, pre-dose, during study and at end of the study Safety and tolerability assessed by the incidence of adverse events, changes in vital signs, clinical laboratory parameters, physical examination findings, and ECG (if applicable). | — |
Countries
Thailand
Contacts
Public ContactDr. Porranee Puranajoti
International Bio Service Co.,Ltd.
Outcome results
None listed