Health Condition 1: I10- Essential (primary) hypertension
Conditions
Interventions
Intervention1: Metoprolol succinate Extended Release Capsule: Dose-50 mg,Frequency-Once daily,Mode of Administration-Oral,Duration of treatment-One week
Control Intervention1: Nil: Nil
Sponsors
Ranbaxy Laboratories Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male patients with age >= 18 to 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To characterize and assess the pharmacokinetic and pharmacodynamic parameters of the sponsorâ??s test formulation (metoprolol succinate extended release 50 mg Capsule) following multiple oral dose administration under fed condition in newly diagnosed hypertensive patients.Timepoint: One week | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the adverse events and to ensure the safety of the patients.Timepoint: One week | — |
Countries
India
Contacts
Public ContactDr Praveen Shetty
Lambda Therapeutic Research Ltd
Outcome results
None listed