| CTRI Number |
CTRI/2021/06/034356 [Registered on: 23/06/2021] Trial Registered Prospectively |
| Last Modified On: |
04/11/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A clinical trial study to determine the bioavailability of different formulations of curcumin tablets. |
|
Scientific Title of Study
|
An open-label, balanced, randomized, single-dose, two-treatment, two-period, two-way crossover, relative bioavailability study of two different formulations of Curcumin 10 mg orally soluble tablet manufactured by KMS Health Center Pvt. Ltd., East Tambaram, Selaiyur, Chennai and Curcunex G 5 mg manufactured by Stabicon Life Science Pvt. Ltd., Plot No 28, Bommasandra industrial area (Sub layout), 4th Phase, Jigani Hobli, Anekal Taluk, Bangalore, Karnataka- 560100. Marketed by Yeus Life science Pvt Ltd, A-IO, Art gold house, Lbs Marg, Mumbai 400070 in healthy, adult, human, male subjects under fasting conditions. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Senthurselvi MBBS MD |
| Designation |
Principal Investigator |
| Affiliation |
Spinos Lifescience and Research Pvt Ltd. |
| Address |
Clinical Trial Division
Spinos Lifescience and Research Pvt Ltd
29 A Krishna Madura vanam
Vellakinar Pirivu G N Mills Post
Coimbatore
TAMIL NADU
641029
India |
| Phone |
|
| Fax |
|
| Email |
senthurselvi.r@spinoslifescience.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Senthurselvi MBBS MD |
| Designation |
Principal Investigator |
| Affiliation |
Spinos Lifescience and Research Pvt Ltd. |
| Address |
Clinical Trial Division
Spinos Lifescience and Research Pvt Ltd
29 A Krishna Madura vanam
Vellakinar Pirivu G N Mills Post
TAMIL NADU
641029
India |
| Phone |
|
| Fax |
|
| Email |
senthurselvi.r@spinoslifescience.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Senthurselvi MBBS MD |
| Designation |
Principal Investigator |
| Affiliation |
Spinos Lifescience and Research Pvt Ltd. |
| Address |
Clinical Trial Division
Spinos Lifescience and Research Pvt Ltd
29 A Krishna Madura vanam
Vellakinar Pirivu G N Mills Post
TAMIL NADU
641029
India |
| Phone |
|
| Fax |
|
| Email |
senthurselvi.r@spinoslifescience.com |
|
|
Source of Monetary or Material Support
|
| KMS Health care Pvt Ltd
No 6 2nd Floor Kamarajar Salai East Tambaram Selaiyur Chennai-600059 |
|
|
Primary Sponsor
|
| Name |
KMS Health Center Pvt Ltd |
| Address |
No 6 2nd Floor Kamarajar Salai East Tambaram Selaiyur Chennai-600059 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Senthurselvi R |
Spinos Lifescience and Research Pvt Ltd |
Clinical Trial Division
Spinos Lifescience and Research Pvt Ltd 29 A Krishna Madura Vanam Vellakinar Pirivu G N Mills Post
Coimbatore
TAMIL NADU |
9750722032
senthurselvi.r@spinoslifescience.com |
|
|
Details of Ethics Committee
|
| 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 |
To monitor the safety and tolerability of a single dose administered in healthy adult human male subjects under fasting conditions |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Curcumin 10 mg tablets |
Single dose - 10 mg tablet
Oral route
|
| Comparator Agent |
Curcunex G 5mg |
Single dose - 5 mg
Oral route |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
Normal, healthy, adult, human male subjects of age between 18-45 years with a Body Mass Index (BMI) ranges between 18.50 kg/m2 to 29.99 kg/m2
Subjects who have no evidence of underlying disease during screening and check-in and whose screening is performed within 21days of check-in.
Subjects whose screening laboratory values are within normal limits or considered by the physician or principal/clinical investigator to be of no clinical significance.
Generally healthy as documented by 12-lead electrocardiogram (ECG), X-Ray and clinical laboratory assessments.
Willing to comply with all requirements of this study protocol as well as instructed by the study personnel. |
|
| ExclusionCriteria |
| Details |
Evidence of allergy or known hypersensitivity to Curcumin or its inactive ingredients.
Renal or liver impairment.
Any disease or condition which might compromise the haemopoeitic, gastrointestinal, renal, hepatic, cardiovascular, Musculoskeletal,
respiratory, central nervous system, diabetes, psychosis or any other body system.
History of alcohol addiction or abuse.
Consumption of caffeine and /or Xanthine containing products (i.e. coffee, tea, chocolate, and caffeine-containing sodas, colas, etc.) 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 72.00 hours prior to check-in and throughout the entire study.
History difficulty in swallowing, 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. |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the Relative Bioavailability of different formulations of Curcumin tablets in healthy adult human male subjects under fasting conditions. |
00.25, 00.50, 01.00, 01.50, 02.00, 02.25, 02.50, 03.00, 03.50, 04.00, 05.00, 06.00, 07.00, 08.00,10.00, 12.00 and 24.00 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To monitor the safety and tolerability of a single dose administered in healthy adult human male subjects under fasting conditions. |
00.25, 00.50, 01.00, 01.50, 02.00, 02.25, 02.50, 03.00, 03.50, 04.00, 05.00, 06.00, 07.00, 08.00,10.00, 12.00 and 24.00 hours. |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
05/07/2021 |
| 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="1"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
To
assess the relative bioavailability of different Curcumin formulations and to monitor the safety and
tolerability of a single dose administered in healthy adult human male subjects
under fasting conditions. Employing
the estimated concentration vs. time profiles ofTotal Curcuminusing WinNonlin® version 8.1 or higher
version of Pharsight Corporation, USA, or
SAS® system for windows version 9.4 or above (SAS®
Institute Inc., USA) or applicable software the following pharmacokinetic
parameters
Statistical analyses for Total Curcumin (will be
done using R-Software or SAS® system for windows version 9.4 or
above (SAS® Institute Inc., USA).
|