To Compare the Pharmacokinetics, Fibrinolytic Activity and Safety of Intravenous Injection of Tenecteplase (Hetero Biopharma Limited) and Reference Medicinal Product (RMP Tenecteplase, Boehringer Ingelheim) in Adults with suspected myocardial infarction with persistent ST elevation.
- Conditions
- Health Condition 1: I41- Myocarditis in diseases classifiedelsewhere
- Registration Number
- CTRI/2021/09/036641
- Lead Sponsor
- PSK Pharma LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Patients and willing to provide written informed consent. Consent from Legally Acceptable Representative (LAR), if patient is not in the condition to give consent. However, when the patient is stable and is able to give consent, consent would be obtained to confirm his/her willingness to continue in the study
- Patients presenting with chest pain and/or symptoms of Acute Myocardial Infarction confirmed by physician with the following ECG changes (12 lead).
a ST elevation of >0.1 mV in two or more limb leads or
b ST elevation of >0.2 mV in two or more contiguous precordial leads
- Subjects presenting with AMI within 6 hours of occurrence of symptoms
- Women of childbearing potential must agree to get pregnancy test done at the time of enrolment and it should be negative.
- Patients with Left Bundle Branch Block (LBBB).
- Patients contraindicated or with history/evidence of hypersensitivity to thrombolytics or any of the components of formulation.
- Patients with history/ active internal active bleeding or hemorrhagic diathesis
- Any known history of hemorrhagic stroke or stroke of unknown origin
- Any history of ischemic stroke or transient ischemic attack in the preceding 6 months
- History of intracranial tumor, arteriovenous malformation, cerebral aneurysm, major surgery, parenchymal biopsy, ocular surgery and/or significant trauma within the past 2 months (this includes any trauma associated with the current AMI).
- Uncontrolled hypertension of systolic BP > 200 mm of Hg and diastolic BP >110 mm of Hg
- Patients administered Tenecteplase in the last 14 days prior to screening for study.
- Patients administered of any glycoprotein IIb/IIIa inhibitor (including abciximab, eptifibatide, sibrafiban and tirofiban) in the 24 hrs prior to screening for study.
- Patients with subacute bacterial endocarditis and clinical pericarditis including pericarditis after this episode of acute myocardial Infarction.
- Patients with high risk as per TIMI risk scoring.
- Where, in the opinion of the investigator, participation in this study will not be in the best interest of the subject, or any other circumstances that prevent the subject from participating in the study safely
- Patients with severe hepatic dysfunction, including hepatic failure, cirrhosis, portal hypertension (oesophageal varices) and active hepatitis
- Patients with any other condition like active peptic ulceration, acute pancreatitis, which investigator feels would pose a significant hazard to subject if IP is administered
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1 Maximum Observed Drug Concentration (Cmax) of Tenecteplase <br/ ><br>2 Area Under the Drug Concentration-time CurveTimepoint: 1 Predose up to 24 h <br/ ><br>2 From Time 0 to 24 h Post-dose (AUC0-24 h) of Tenecteplase Time Frame- predose up to 24 h <br/ ><br>
- Secondary Outcome Measures
Name Time Method Area Under the Drug Concentration-time CurveTimepoint: From Time 0 to infinity Post-dose (AUC0-inf) of Tenecteplase;AUEC0-24hTimepoint: will be estimated using the linear-log trapezoidal method.;Fibrinolytic activityTimepoint: using Euglobulin lysis time (ELT) method;Half-life (T1/2) of TenecteplaseTimepoint: Time Frame: Day 1 predose up to 24 h;Number of Participants With Adverse EventsTimepoint: Time Frame: From the first dose of tenecteplase through