An Open Label, Two Treatments, Single Dose, Cross Over, Bioequivalence Study of Valsatril Tablet of SAMI Pharmaceuticals Pvt. Ltd. Versus Entresto® Tablet of Novartis Pharmaceuticals Ltd., Under Fasting Condition in Adult Healthy Subjects.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- AUC
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Test Group
Oral administration of Valsatril (Sacubitril/Valsartan) 24/26 mg Tablet with 240 mL of ambient temperature water after at least 10 hours fast at their specified dosing time-points.
干预措施: Valsatril® (Drug)
Reference Group
Oral administration of Entresto (Sacubitril/Valsartan) 24/26 mg Tablet with 240 mL of ambient temperature water after at least 10 hours fast at their specified dosing time-points.
干预措施: Entresto® (Drug)
结局指标
主要结局
AUC
时间窗: 0-48 hours post dose
Area under the plasma drug concentration time curve
Cmax
时间窗: 0 - 48 hours post dose
Maximum Plasma Concentration
次要结局
- Tmax,(0-48 hours post dose)
- t1/2(0-48 hours post dose)
- Body temperature(0-48 hours post dose)
- Heart rate.(0-48 hours post dose)
- Blood Pressure(0-48 hours post dose)
研究者
Dr. Naghma Hashmi
Co-principal Investigator
Center for Bioequivalence Studies and Clinical Research