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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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)  

Background

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.

 

 

Study Rationale:

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. 

 
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