None listed
Conditions
Interventions
Intervention1: PeaNoc XL: Palmitoylethanolamide 400mg and Astaxzanthin 01mg
after food two times a day for 14days by oral route of administration
Control Intervention1: Placebo: For first 14 days, 50
Sponsors
Apex Laboratories Pvt Ltd
SRM INSTITUTE OF SCIENCE AND TECHNOLOGY
Eligibility
Inclusion criteria
Inclusion criteria: ââ?¬Â¢ Healthy male volunteers of 18-45 years (both years inclusive) and body weight > 50 kg. ââ?¬Â¢ Willing to give informed written consent and comply with the study requirements. ââ?¬Â¢ Subject should be able to communicate effectively. ââ?¬Â¢ Non-smokers or individuals who smoke less than 5 cigarettes per day ââ?¬Â¢ Teetotalers or individuals who drink less than 60 ml of high-alcohol-content liquor or 120 ml of low-alcohol-content liquor ââ?¬Â¢ Body Mass Index (BMI) between 18.50 and 24.99 Kg/m2 ââ?¬Â¢ Healthy individuals as evaluated by personal history, medical history and general clinical examination. ââ?¬Â¢ Vital parameters - BP should be within the range of 100 ââ?¬â?? 139 mmHg systolic and 60 ââ?¬â?? 89 mmHg diastolic. Pulse rate should be within the range of 60 ââ?¬â?? 100 / min. Oral temperature between 97.8Ã?Å¡ F and 99.0 Ã?Å¡ F. Respiratory rate should be within the range of 14-18/min. ââ?¬Â¢ Normal biochemical, hematological and urinary parameters. ââ?¬Â¢ Normal Chest X-ray PA view & ECG in 12 leads. ââ?¬Â¢ Negative for HIV 1 & 2, Hepatitis B, Hepatitis C and Syphilis tests. ââ?¬Â¢ Negative urine test for drugs of abuse for morphine, barbiturates, benzodiazepines, amphetamine, THC & cocaine (to be performed on the day of check-in). ââ?¬Â¢ Negative alcohol breath analysis (to be performed on the day of check-in)
Exclusion criteria
Exclusion criteria: 1) History suggestive of cardiac, gastrointestinal, respiratory, hepatic, renal, endocrine, neurological, metabolic, psychiatric or hematological systems, judged to be clinically significant 2) subjects incapable of understanding the informed consent and not willing to participate in the study 3) hypersensitivity to study formulation 4) history of drug abuse 5) history of hypersensitivity to study drug and allergic to any vegetables or foods
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| This study is designed to evaluate the drug interaction potential of multiple oral doses of PeaNoc XL based on the pharmacokinetic parameters (AUC, Cmax, Tmax, t1/2, CL, Vd) changes of simvastatin. Timepoint: 18weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Monitoring adverse Drug reactions during the study periodTimepoint: 16weeks | — |
Countries
India
Contacts
Public ContactASVITHA G
SRM Institute of Science and Technology
Outcome results
None listed