| CTRI Number |
CTRI/2024/11/077316 [Registered on: 25/11/2024] Trial Registered Prospectively |
| Last Modified On: |
10/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A Double Blind Balanced Randomized Single Dose Two Treatment Two Sequence Two Period Two Way Crossover Oral Bioavailability Study Comparing Curcumin 1000 mg Hard Capsule |
|
Scientific Title of Study
|
A Double Blind Balanced Randomized Single Dose Two Treatment Two Sequence Two Period Two Way Crossover Oral Bioavailability Study Comparing Cocrystal Curcumin 1000 Mg Hard Capsule 4 X 250 Mg Manufactured By Wei Hai Sai Rui Space Technology Co Ltd 175 2 Dongan Road Economic And Technological Development Zone Weihai City Shandong Province, China With Doctors Best Curcumin 1000 Mg Hard Capsule 2 X 500 Mg Manufactured By 18100 Von Karman Avenue Suite 800 Irvine Ca 92612 United State In Healthy Adult Human Subjects Under Fasting Conditions |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SLS-CT-0017-24-CURC Version 01 Dated 16 Oct 24 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pradeep T |
| Designation |
Principal Investigator |
| Affiliation |
Spinos Lifescience and research private limited |
| Address |
Clinical Pharmacology Unit Ground Floor No 29 A Krishna Madhuravanam Vellakinar Pirivu
Thudiyalur
Coimbatore
TAMIL NADU
641029
India |
| Phone |
08220586899 |
| Fax |
|
| Email |
pradeep.t@spinoslifescience.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pradeep T |
| Designation |
Principal Investigator |
| Affiliation |
Spinos Lifescience and research private limited |
| Address |
Clinical Pharmacology Unit Ground Floor No 29 A Krishna Madhuravanam Vellakinar Pirivu
Thudiyalur
TAMIL NADU
641029
India |
| Phone |
08220586899 |
| Fax |
|
| Email |
pradeep.t@spinoslifescience.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep T |
| Designation |
Principal Investigator |
| Affiliation |
Spinos Lifescience and research private limited |
| Address |
Clinical Pharmacology Unit Ground Floor No 29 A Krishna Madhuravanam Vellakinar Pirivu
Thudiyalur
TAMIL NADU
641029
India |
| Phone |
08220586899 |
| Fax |
|
| Email |
pradeep.t@spinoslifescience.com |
|
|
Source of Monetary or Material Support
|
| Cocrystal Health Industry Zhejiang Co Ltd 188 Guigu Six Road Jiashan Zhejiang PR China 314100 |
|
|
Primary Sponsor
|
| Name |
Cocrystal Health Industry Zhejiang Co Ltd |
| Address |
188 Guigu Six Road Jiashan Zhejiang PR China 314100 |
| Type of Sponsor |
Other [Neutraceuticals] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Spinos Life Science and Research Private limited |
Clinical Pharmacology Unit Ground Floor Spinos Life science and Research Private Limited No 29 A Krishna Madhuravanam Vellakinar Pirivu Thudiyalur
Coimbatore
TAMIL NADU |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pradeep T |
Spinos Life science and Research private limited |
Clinical Pharmacology Unit Ground Floor Spinos Life science and Research Private Limited No 29 A Krishna Madhuravanam Vellakinar Pirivu Thudiyalur
Coimbatore
TAMIL NADU |
08220586899
pradeep.t@spinoslifescience.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Fasting Conditions |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
Cocrystal Curcumin 1000 mg Hard Capsule 4 X 250 mg |
Single oral dose of Curcumin 100mg Hard capsules Will Be Administered in each period 10 Days Duration |
| Intervention |
Doctors Best Curcumin 1000 mg Hard Capsule 2 X 500mg |
Single oral dose of Curcumin 100mg Hard capsules Will Be Administered in each period 10 Days Duration |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Normal healthy adult human male and or female subjects of age between 18 to 45 years and Body Mass Index BMI ranges between 18.50 kg per m2 to 30.00 kg per m2
Subjects who have no evidence of underlying disease during screening and check in and whose screening is performed within 21 days of check in
Subjects whose screening laboratory values are within normal limits are considered by the physician or principal/clinical investigator to be of no clinical significance
Healthy as do cumented by the medical history including vitamins and dietary supplements physical examination including but not limited to an evaluation of the cardiovascular gastrointestinal respiratory musculoskeletal and central nervous system and vital sign assessments
Generally healthy as documented by a 12 lead electrocardiogram ECG Chest X Ray and clinical laboratory assessments
Willing to consume Ovo lacto vegetarian diet
All subjects will be instructed to have all meals free of turmeric starting at least 07 days before period I till the end of period II and all in house meals will also be given free of turmeric
Willing to comply with all requirements of this study protocol as well as instructions from the study personnel
Non smokers |
|
| ExclusionCriteria |
| Details |
Evidence of allergy or known hypersensitivity to Curcumin or its inactive ingredients
Subjects with hepatic encephalopathy cholestasis myasthenia pre existing liver disease alcohol abuse existing tinnitus and pre existing gallbladder disease
Any major illness in the last three months or any significant ongoing chronic medical illness
Renal or liver impairment
Any disease or condition that might compromise the haemopoeitic gastrointestinal renal hepatic cardiovascular Musculoskeletal respiratory central nervous system or any other body system including presence of Diabetes Mellitus and Psychosis
History of alcohol addiction or abuse
Consumption of caffeine and /or xanthine containing products ie coffee tea chocolate caffeine containing sodas colas etc cigarettes and tobacco containing products for at least 48 00 hours prior to check in and throughout the entire study
Consumption of alcohol and its products grapefruit and/or its juice and poppy containing foods within 48 00 hours prior to clinic admission and throughout the entire study
Subjects who have taken any prescription medications vitamins and dietary supplements within 14 days prior to study check in and throughout the study and any over the counter medicinal products herbal medications within 07 days prior to study check in and throughout the study
Subjects who have taken any unusual diet for whatever reason eg low salt for 48 00 hours prior to dosing and throughout the study
Subject who had participated in any other study within the 90 days of check-in
History of difficulty in swallowing
History of difficulty in accessibility of veins
Positive results for urine screen of drugs of abuse Marijuana THC amphetamine AMP barbiturates BAR cocaine COC benzodiazepines BZD and morphine MOR in urine prior to check-in of each period
Positive results for alcohol test prior to check in of each period
Any blood donation excess blood loss within 90 days of check in
Ingestion of any hormonal agent at any time within 14 days prior to the start of the study check in
Use of hormone replacement therapy for a period of 06 months prior to dosing
Female subjects demonstrating a positive pregnancy screen
Female subjects who are currently lactating
Females are likely to become pregnant during the course of the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the Bioavailability of Crysvital Curcumin 1000 mg Hard Capsule (2 X 500mg) Manufactured by Wei Hai Sai Rui Space Technology Co Ltd No 175 2 Dong an Road, Economic and Technological Development Zone Weihai City Shandong Province China with Doctors Best Curcumin 1000 mg Hard Capsule (2 X 500mg) Manufactured by 18100 Von Karman Avenue Suite 800 Irvine CA 92612 United State In Healthy Adult Human Subjects Under Fasting Conditions |
15 Time Points
-12 00 hrs 00 00 hrs 00 50 hrs 01 00 hrs 02 00 hrs 02 50 hrs 03 00 hrs 03 50 hrs 04 00 hrs 04 50 hrs 05 00 hrs 06 00 hrs 08 00 hrs 10 00 hrs 24 00 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To monitor the safety and tolerability of test product comparing with the reference product in healthy, adult, human subjects under fasting conditions |
15 Time Points
-12 00 hrs 00 00 hrs 00 50 hrs 01 00 hrs 02 00 hrs 02 50 hrs 03 00 hrs 03 50 hrs 04 00 hrs 04 50 hrs 05 00 hrs 06 00 hrs 08 00 hrs 10 00 hrs 24 00 hrs |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/12/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
At least 12 number of healthy adult human subjects will be recruited to evaluate the Bioavailability of Test product with the Reference product In each period subjects will be housed in the clinical facility for at least 14 00 hrs pre dose to 24 00 hrs post dose A washout period of at least 07 days will be maintained between each dosing period In each period, after an overnight fasting of at least 10 00 hrs, in the morning a single oral dose of either the test product T or reference product R will be administered as per the randomization schedule with 240 mL of drinking water at ambient temperature, to the subjects sitting in upright posture, under the supervision of the investigator or medical officer and/or trained study personnel, including the quality assurance auditors or monitor. Blood pressure, radial pulse rate, body temperature, and wellbeing status will be enquired and recorded at pre-dose 00.00 hour within 75 minutes of before dosing and at 01 00 hrs 03 00 hrs 05 00 hrs 07 00 hrs and 12 00 hrs plus or minus 60 minutes post dose Physical examination and vitals will be recorded before check in check out 24 00 hrs for each period and at any time if necessary. Monitoring for adverse events will be done throughout the study period in clinical phase |