Healthy Participants
Conditions
Keywords
Bioequivalence, Sacubitril, Valsartan, Pakistan
Brief summary
This study is to evaluate the bioequivalence of Valsatril (Sacubitril/Valsartan) tablet 50 mg versus Entresto 50 mg tablet in healthy Pakistani volunteers under Fasting condition.
Detailed description
This will be a randomized, open-label, single-center, single-dose, two-treatment, two-period, two sequence crossover bioequivalence study in healthy adult participants with at least a 7-day washout period between treatment administrations. A sufficient number of participants were screened to randomize approximately 60 participants, Participants were randomly assigned to one of the two treatment sequences and receive a single dose of each treatments in each (of 2) periods following a crossover design. Blood was sampled regularly at scheduled times for 48 hours following treatment in each period to assess the pharmacokinetic parameters.
Interventions
DRUGValsatril®
(Sacubitril/Valsartan) 24 mg/26 mg tablet of SAMI Pharmaceuticals (Pvt) Ltd
DRUGEntresto®
Entresto® (Sacubitril/Valsartan) 24 mg/26 mg tablet of Novartis Pharmaceuticals Ltd
Sponsors
Center for Bioequivalence Studies and Clinical Research
SAMI Pharmaceuticals (Pvt.) Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open label, randomized, single-dose, two way cross-over study
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy volunteers aged 18 to 55 years inclusive. * Subjects with a body mass index from 18.5 to 30 kg/m2 (both inclusive). * Subjects who are healthy as determined by routine physical examination, including vital sign monitoring and laboratory analysis (i.e., hematology, blood biochemistry, and urinalysis). * Subjects should have negative urine test for drugs of abuse and alcohol breath analysis at screening and prior to each check-in. * All subjects should be free from any epidemic or contagious diseases (e.g., Malaria, Dengue, Covid-19) * Subjects agreed to sign the Informed Consent Form * Subjects agreed not to consume grapefruit and/or its products within 14 days prior to the start of study. * Subjects agreed to discontinue Vitamin, dietary supplements and herbal products 14 days prior to the first dose of study medication.
Exclusion criteria
* Inability to take oral medication * History of smoking (≤3 cigarette/day), alcoholism, and positive test for drug of abuse, heavy pan or gutka user as judged by teeth / mouth inspection. Subjects with clinically relevant evidence of cardiovascular, gastrointestinal/hepatic, renal, psychiatric, respiratory, urogenital, hematologic/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological /connective tissue, musculoskeletal, metabolic/nutritional, endocrine, allergy, or other relevant diseases as revealed by medical history, physical examination, and laboratory assessments which may interfere with the absorption, distribution, metabolism or elimination of drugs or constitute a risk factor when taking study medication.. * Known hypersensitivity to any xenobiotic and Sacubitril/Valsartan or any of the excipients. * A prior history of angioedema due to an ACEI or ARB. * Subject received any of the investigational drug within four weeks. * Subjects with salt imbalance in the blood (especially high levels of potassium in the blood). * Donation or loss of more than 400 mL of blood within 3 months prior to the screening. * Ingestion of OTC drug, within 07 days of drug administration. * History of intake of any prescribed medicine during a period of 14 days, prior to drug administration * Subjects who test positive for syphilis (VDRL) or who are known to have serum hepatitis or who are carriers of the Hepatitis B surface antigen (HBs Ag) or are carriers of antibodies to hepatitis C virus (anti-HCV) or to the human immunodeficiency virus (HIV-1 or HIV-2). * Subject with history of any illness that, in the opinion of investigator might confound the result of the study or post additional risk in administrating Sacubitril /Valsartan to the subjects.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC | 0-48 hours post dose | Area under the plasma drug concentration time curve |
| Cmax | 0 - 48 hours post dose | Maximum Plasma Concentration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tmax, | 0-48 hours post dose | Time required for maximum plasma drug concentration, |
| t1/2 | 0-48 hours post dose | Half Life. |
| Blood Pressure | 0-48 hours post dose | monitoring of blood pressure both systolic pressure and diastolic pressure, after dose administration |
| Body temperature | 0-48 hours post dose | post dose body temperature measurement |
| Heart rate. | 0-48 hours post dose | Measurement of heart rate after dosing.. |
Countries
Pakistan
Contacts
PRINCIPAL_INVESTIGATORDr. M. Raza Shah
Center for Bioequivalence Studies and Clinical Research
PRINCIPAL_INVESTIGATORDr. Naghma Hashmi
Center for Bioequivalence Studies and Clinical Research
Outcome results
None listed