None listed
Conditions
Interventions
Intervention1: Fixed dose combination of Propoxyphene napsylate 100mg and Paracetamol 400 mg: Each dose is to be administered thrice a day (one capsule 06 hourly) for 05 consecutive days with 240 ± 2
Sponsors
Wockhardt Limited
Eligibility
Inclusion criteria
Inclusion criteria: Willingness to provide written informed consent Healthy males within 18-45 years of age (inclusive) Body-mass index of more than or equal to 19.0 kg/m2 and less than or equal to 30.0 kg/m2, with body weight not less than 50 kg No evidence of underlying disease during the screening medical history, physical examination and clinically significant abnormal laboratory values at the pre-study screening Willingness to abstain from use of cigarettes and tobacco products for at least 24 hrs prior to first dosing and throughout the study period Normal 12-lead ECG with no abnormalities of rate, rhythm, or conduction (i.e., normal PR interval of 0.12-0.2 sec, normal QRS duration of 0.06-0.1 sec), Chest X-ray PA view Screening laboratory tests within normal limits or clinically non-significant as per discretion of the Principal Investigator Availability of subject for the entire study period, ability to understand and communicate with the investigators and staff
Exclusion criteria
Exclusion criteria: 1. Known history of long-QT syndrome or any other cardiac conditions like Coronary artery disease (CAD), ischemic heart disease (IHD), angina, myocardial ischemia or infarction, myocarditis, chest pain or dyspnea on exertion, heart failure, heart tumor or cardiac conduction disorders, or electrolyte abnormalities or abnormal blood pressure 2. A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 milliseconds (ms)) 3. A history of additional risk factors for TdP (e.g., heart failure, hypokalemia, family history of Long QT Syndrome) 4. The use of concomitant medications like beta blockers and calcium channel blockers that prolong the QT/QTc interval 5. Consumption of muscle relaxants, antidepressants, or other CNS-depressant drugs 6. Subjects with suicidal or suicidal ideation. 7. Subjects with history or presence of renal or hepatic disease. 8. Subjects with abnormal laboratory values of liver function test and kidney function test. 9. History or presence of addiction (Smoking, alcohol, drug) 10. Known hypersensitivity to the drug or to any of the ingredients of the Investigational products. 11. Subjects who have taken any investigational drug within 90 days prior to dosing.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The effect on QT/QTc interval will be analysed using the largest time-matched mean difference between Proxyvon and placebo (baseline adjusted)(Î?QTc). The effect size will be determined as the time-matched, baseline-adjusted QT/QTc interval value for Proxyvon vs placebo (Î?Î?QTc). Measurement of the PR interval, P wave size, QRS width (interval), QT interval, Abnormal Q waves, ST segments, T waves and U waves will be performed Pre-cordial leads and lead II will be used to measure QT intervalTimepoint: baseline and 1.75 hrs, 2.25 hrs, 2.75 hrs, 3.50 hrs, 4.00 hrs, 4.50 hrs, 72 hrs and 168 hrs post dose | — |
Secondary
| Measure | Time frame |
|---|---|
| SafetyTimepoint: recorded during the entire study period | — |
Countries
India
Contacts
Public ContactMs Seema Bawangade
Wockhardt Limited
Outcome results
None listed