CTRI Number |
CTRI/2015/07/005993 [Registered on: 14/07/2015] Trial Registered Prospectively |
Last Modified On: |
28/11/2019 |
Post Graduate Thesis |
No |
Type of Trial |
BA/BE |
Type of Study
|
|
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Comparative bioavailability study of four different Curcumin formulations in 20 Healthy adult human male subjects under fasting conditions. |
Scientific Title of Study
|
An open label, balanced, randomized, parallel, single dose, comparative bioavailability study of four different Curcumin formulations (containing Curcumin 600mg) of Sanat Products Ltd., India in 20 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 Pankaj Bablani |
Designation |
Principal Investigator |
Affiliation |
Auriga Research Limited |
Address |
3/15, Kirti Nagar Industrial Area,
New Delhi – 110015
3/15, Kirti Nagar Industrial Area,
New Delhi – 110015 West DELHI 110015 India |
Phone |
011-45754537 |
Fax |
|
Email |
pankaj.bablani@aurigaresearch.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Bharathi Dhasan P |
Designation |
Head R & D |
Affiliation |
Sanat Products Ltd., |
Address |
B-8, Industrial Area,
Sikandrabad, BulandShahar,
UP – India
B-8, Industrial Area,
Sikandrabad, BulandShahar,
UP – India Bulandshahar UTTAR PRADESH 203205 India |
Phone |
05735-222415 |
Fax |
|
Email |
bdhasan@sanat.co.in |
|
Details of Contact Person Public Query
|
Name |
Dr Manoj Karwa |
Designation |
Head-Clinical Unit |
Affiliation |
Auriga Research Limited |
Address |
3/15, Kirti Nagar Industrial Area,
New Delhi 3/15, Kirti Nagar Industrial Area,
New Delhi West DELHI 110015 India |
Phone |
011-45754540 |
Fax |
|
Email |
manojkarwa@aurigaresearch.com |
|
Source of Monetary or Material Support
|
Sanat Products Ltd.,
B-8, Industrial Area,
Sikandrabad, BulandShahar,
UP – India
Pin- 203205
|
|
Primary Sponsor
|
Name |
Sanat Products Ltd |
Address |
B-8, Industrial Area,
Sikandrabad, BulandShahar,
UP – India
Pin- 203205
|
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 Pankaj Bablani |
Auriga Research Limited, |
3/15, Kirti Nagar Industrial Area,
New Delhi – 110015 West DELHI |
011-45754546
pankaj.bablani@aurigaresearch.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Good Society for Ethical Research |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
Healthy adult human male subjects meeting inclusion and exclusion criteria |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Alzeimeromin Capsule
|
600mg / 2 cap of Sanat Products Ltd., India
single dose, duration-one day |
Comparator Agent |
Curcunan Capsule
|
600mg / 2 cap of Sanat Products Ltd., India
single dose, duration-one day |
Intervention |
Theracurmin Capsule
|
600mg / 2 cap of Sanat Products Ltd., India
single dose, duration-one day |
Intervention |
Turmix Capsule
|
600mg / 2 cap
of Sanat Products Ltd., India
single dose, duration-one day |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
45.00 Year(s) |
Gender |
Male |
Details |
i. Subject who are able and ready to provide written informed consent.
ii. Subjects must be healthy male human beings within 18-45 years of age (both inclusive).
iii. Subjects should be having Body Mass Index (BMI) in the range 18.5-30 kg/m2, weighing at least 50 kg.
iv. Subjects must be of normal health as determined by medical history, physical examination, ECG and laboratory tests performed within 21 days prior to the commencement of the study.
v. Subjects whose screening laboratory values are within normal limits or considered by the physician / Principal Investigator to be of no clinical significance
|
|
ExclusionCriteria |
Details |
i. Subjects incapable of understanding the informed consent process or not ready to sign informed consent.
ii. Subjects with significant history of hypersensitivity to Curcumin or any ingredients of the formulation or any related products as well as severe hypersensitivity reactions (like angioedema) to any drugs.
iii. Subject with of presence or history of significant gastrointestinal, liver or kidney disease, or any conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects.
iv. Subjects with active peptic ulceration or a history of peptic ulceration.
v. Subject with resting hypotension (BP <90 /60) or hypertension (BP > 139 /89).
vi. Subject with Pulse rate 50/ min. and above 99/min.
vii. Subjects with or prior history of clinically significant, Cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease.
viii. Subjects with a history of MI, Stroke, Peripheral Arterial Disease, GI Bleeding, Hepatic-Impairment, Renal Impairment, Epilepsy and Intracranial hemorrhage.
ix. Subjects with a history of known food allergy.
x. Subjects who have suffered any illness or who have been hospitalized within the last 4 weeks preceding the start of the study. |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
To assess the bioavailability of single oral formulation of four different Curcumin formulations (containing Curcumin 600mg) of Sanat Products Ltd., India in 20 Healthy adult human male subjects under fasting conditions. |
Pre dose (00.00 hour) sample will be collected within 02 hours prior to Investigational Product administration and the post dose samples will be collected at 00.25, 00.50, 00.75, 01.00, 01.25, 01.50, 01.75, 02.00, 02.50, 03.00, 04.00, 06.00, 08.00 and 10.00 hours respectively. |
|
Secondary Outcome
|
Outcome |
TimePoints |
To monitor adverse events and assess safety and tolerability of Curcumin under fasting condition. |
Vital signs - sitting blood pressure, radial pulse rate, oral temperature will be assessed at admission, prior to dosing (00.00 hrs) and at 02.00, 06.00 and 12.00 hours post-dose and at the time of checkout (24.00 hrs). |
|
Target Sample Size
|
Total Sample Size="20" Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" |
Phase of Trial
|
Phase 4 |
Date of First Enrollment (India)
|
12/08/2015 |
Date of Study Completion (India) |
21/09/2015 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="0" Months="3" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
none yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Turmeric, the source of the polyphenolic active compound curcumin (diferuloylmethane), has been used extensively in traditional medicine since ancient times as a household remedy against various diseases, including hepatic disorders, cough, sinusitis, rheumatism, and biliary disorders. Recently a large number of studies have shown that curcumin (CU) has a surprising array of antioxidant, antitumor, anti-inflammatory, anticancer, and other desirable medicinal properties. There is scientific evidence suggesting that CU has a highly pleotropic structure, that physically interacts with a wide range of molecular targets, e.g., transcription factors, growth factors and their receptors, cytokines, enzymes, and genes regulating cell proliferation. Curcumin (CU) functions as an anti-cancer agent by activating apoptosis signaling and inhibiting cell proliferation. CU has been shown to suppress the expression of epidermal growth receptor and estrogen receptors, which are cancer-associated growth factors (Duvoix et al., 2003; Tapal and Tiku, 2012). However, the main drawback associated with CU is its poor aqueous solubility (11 ng/mL) (Kaminaga et al., 2003), stability in gastrointestinal fluids, low permeability and first pass metabolism which leads to poor bioavailability (~1% in rat) (Pan et al., 1999; Yang et al., 2007). CU is a BCS Class IV (low solubility low permeability) molecule (Wahlang et al., 2011). In order to deliver CU to targeted organs, its hydrophobic property needs to be modified. The small size of carriers is very important for the biodistribution in the body. The capillaries are so small that red blood cells can only travel through them in single file. The capillaries measure approximately 5–10 μm in diameter. Particles larger than this size cannot be circulated in the body and become entrapped in the capillary bed. Thus, the particle diameter should be generally smaller than micrometers for the particles to be circulated in the blood vessels. In addition, reduction in the particle diameter to less than 100 nm is thought to decrease their removal by thereticuloendothelial system and increase their extravasations from the smallest capillaries. Thus, nanotechnology is one of the effective methods to be used for the delivery of CU. The rational for the present study was to increase the bioavailability of Curcumin for increasing the therapeutic effectiveness against different ailments using Nano particle size of Curcumin in tablet form through oral route as the drug delivery approach. The study has been designed to augment the in vitro release by improving solubility and permeability using Curcumin Nanoparticles and to enhance the bioavailability of Curcumin by delivering it at the molecular level in the form of nano particles. |