| CTRI Number |
CTRI/2021/10/037480 [Registered on: 22/10/2021] Trial Registered Prospectively |
| Last Modified On: |
04/02/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Non-randomized, Placebo Controlled Trial |
|
Public Title of Study
|
Clinical Pharmacokinetic drug interaction study between simvastatin and PeaNoc XL |
|
Scientific Title of Study
|
A Phase 1 single Centre randomized double blind placebo controlled Clinical Pharmacokinetic drug interaction study between simvastatin and PeaNoc XL in Adult Healthy Human volunteers |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
R C SATISH KUMAR |
| Designation |
Associate Professor |
| Affiliation |
SRM Institute of Science and Technology |
| Address |
Interdisciplinary Institute of Indian Systems of Medicine, SRM IST, Kattankulathur-603203.
Kancheepuram
TAMIL NADU
603203
India
SRM COLLEGE OF PHARMACY
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9884845887 |
| Fax |
|
| Email |
ayursatish@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
T M VIJAYAKUMAR |
| Designation |
Associate Professor and Head |
| Affiliation |
SRM Institute of Science and Technology |
| Address |
No: 301 Department of Pharmacy Practice, SRM College of Pharmacy, SRM Institute of Science and Technology, Kattankulathur
Kancheepuram
TAMIL NADU
603203
Indi
SRM COLLEGE OF PHARMACY
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9003400350 |
| Fax |
|
| Email |
vijaypractice@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
ASVITHA G |
| Designation |
PHARM.D [Intern] |
| Affiliation |
SRM Institute of Science and Technology |
| Address |
No:301 Department of Pharmacy Practice, SRM College of Pharmacy, SRM Institute of Science and Technology, Kattankulathur
Kancheepuram
TAMIL NADU
603203
Indi
Kancheepuram
TAMIL NADU
60203
India |
| Phone |
8098407611 |
| Fax |
|
| Email |
ashvithaa0609@gmail.com |
|
|
Source of Monetary or Material Support
|
| Metabolic ward, Clinical Trial and Research Unit, SRM Medical College Hospital and Research Centre, No:o1, 4th floor,SRM Medical College Hospital and Research Centre, SRM Institute of Science and Technology, Kattankulathur, 603203. Kancheepuram TAMIL NADU
|
|
|
Primary Sponsor
|
| Name |
Apex Laboratories Pvt Ltd |
| Address |
29, Guindy, Chennai, Tamil Nadu 600032 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| SRM INSTITUTE OF SCIENCE AND TECHNOLOGY |
Potheri, SRM Nagar, Kattankulathur, Tamil Nadu 603203 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Melvin George |
Metabolic ward, Clinical Trial and Research Unit, SRM Medical College Hospital and Research Centre |
No:o1, 4th floor,SRM Medical College Hospital and Research Centre, SRM Institute of Science and Technology, Kattankulathur, 603203.
Kancheepuram
TAMIL NADU
Kancheepuram
TAMIL NADU |
9894133697
melvingeorge2003@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM MEDICALCOLLEGE HOSPITAL RESEARCH CENTRE INSTITUTIONAL ETHICS COMMITEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
the volunteers having good digestive capacity and normal bowel habit
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
PeaNoc XL |
Palmitoylethanolamide 400mg and Astaxzanthin 01mg
after food two times a day for 14days by oral route of administration |
| Comparator Agent |
Placebo |
For first 14 days, 500 mg of the Placebo(sugar pill) will be given twice a day.
|
| Comparator Agent |
Simvastatin |
on 15th day morning, 20mg of single oral dose simvastatin tablet will be given for both the groups
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
• Healthy male volunteers of 18-45 years (both years inclusive) and body weight > 50 kg.
• Willing to give informed written consent and comply with the study requirements.
• Subject should be able to communicate effectively.
• Non-smokers or individuals who smoke less than 5 cigarettes per day
• Teetotalers or individuals who drink less than 60 ml of high-alcohol-content liquor or 120 ml of low-alcohol-content liquor
• Body Mass Index (BMI) between 18.50 and 24.99 Kg/m2
• Healthy individuals as evaluated by personal history, medical history and general clinical examination.
• Vital parameters - BP should be within the range of 100 – 139 mmHg systolic and 60 – 89 mmHg diastolic. Pulse rate should be within the range of 60 – 100 / min. Oral temperature between 97.8˚ F and 99.0 ˚ F. Respiratory rate should be within the range of 14-18/min.
• Normal biochemical, hematological and urinary parameters.
• Normal Chest X-ray PA view & ECG in 12 leads.
• Negative for HIV 1 & 2, Hepatitis B, Hepatitis C and Syphilis tests.
• Negative urine test for drugs of abuse for morphine, barbiturates, benzodiazepines, amphetamine, THC & cocaine (to be performed on the day of check-in).
• Negative alcohol breath analysis (to be performed on the day of check-in) |
|
| ExclusionCriteria |
| Details |
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 |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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. |
18weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Monitoring adverse Drug reactions during the study period |
16weeks |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/11/2021 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="25" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Publication work will commence after finishing the theoretical section. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
PeaNoc XL has been used for the treatment of inflammatory and chronic pain etc. However, the information regarding the ADME parameter and drug interaction potential of PeaNoc XL have not been investigated and hence the present study aimed to determine the drug interaction potential of PeaNoc XL by estimating the pharmacokinetic parameters (AUC, Cmax, Tmax, t1/2, CL, Vd.) changes of simvastatin |