An open label, multicenter, single arm, multiple Oral dose study to evaluate the Pharmacokinetic- Pharmacodynamic correlation of Metoprolol succinate extended-release 50 mg capsule in newly diagnosed hypertensive patients under fed conditions. - NA

Ranbaxy Laboratories Ltd0 个研究点目标入组 24 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1.Male patients with age >= 18 to < 65 years at the screening visit.
•2.Having a Body Mass Index (BMI) between 18.5 and 27.0
•3.Newly diagnosed patient of essential hypertension
•4.Patient should be able to comply with study procedures in the opinion of the investigator.

•1.Hypersensitivity or suspected contraindication to metoprolol or any of its excipients.
•2.Patient receiving any antihypertensive
•3. Any history or presence of clinically significant evidence of secondary form of hypertension
•4.Patient with uncontrolled Type 1 or Type 2 diabetes mellitus
•5.Any history or presence of asthma or nasal polyp or NSAID induced urticaria
•6.Existence of any surgical or medical condition which might interfere with the absorption, distribution, metabolism or excretion of the study drug
•7.Ingestion or use of any medication at any time within 14 days prior to start of dosing.
•8. Any history or presence of clinically significant cardiovascular, respiratory, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, cancer, neurologic or psychiatric disease or any other condition which, in the opinion of the investigator, would jeopardize the safety of the patient
•9. Donation of blood (1 unit or 350 ml) within 90 days prior to receiving the first dose of investigational medicinal product
•10.15. The receipt of an investigational medicinal product within a period of 30 days prior to the study.
•11.History of drug or alcohol abuse
•12.Patients with history of human immunodeficiency virus (HIV) infection, including positive HIV results.

发起方

Ranbaxy Laboratories Ltd