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CTRI Number  CTRI/2016/05/006938 [Registered on: 16/05/2016] Trial Registered Prospectively
Last Modified On: 28/11/2019
Post Graduate Thesis  No 
Type of Trial  BA/BE 
Type of Study    
Study Design  Randomized, Crossover Trial 
Public Title of Study   Bioavailability study of Curcuminoids capsules of Triokka Pharmaceuticals Private Limited, India with Meriva-SR of Throne Research Inc., USA in 8 Healthy adult human male subjects under fasting conditions. 
Scientific Title of Study   An open label, Randomized, Two treatment, Two-period, Two-sequence, Two-way crossover, pilot comparative bioavailability study of Curcuminoids capsules of Troikaa Pharmaceuticals Ltd., India with Meriva-SR® of Thorne Research, Inc., USA, in healthy adult subjects, under fasting condition. 
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 Private Limited 
Address  Auriga Research Private Limited, 3/15, Kirti Nagar Industrial Area, New Delhi

West
DELHI
110015
India 
Phone  9311234776  
Fax    
Email  pankaj.bablani@aurigaresearch.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jyoti Paliwal 
Designation  Medical Advisor- Medical Services 
Affiliation  Troikaa Pharmaceuticals Limited 
Address  Troikaa Pharmaceuticals Limited Commerce House 1, Opp. Rajvansh Apartment, Satya Marg, Bodakdev. Ahmedabad

Ahmadabad
GUJARAT
380054
India 
Phone  9909957477  
Fax    
Email  jyotikumar@troikaapharma.com  
 
Details of Contact Person
Public Query  
Name  Dr Manoj Karwa 
Designation  Head-Clinical Unit 
Affiliation  Auriga Research Private Limited 
Address  Auriga Research Private Limited, 3/15, Kirti Nagar Industrial Area, New Delhi

West
DELHI
110015
India 
Phone  011-45744540  
Fax    
Email  manojkarwa@aurigaresearch.com  
 
Source of Monetary or Material Support  
Troikaa Pharmaceuticals Limited, Commerce House 1, Opp. Rajvansh Apartment, Satya Marg, Bodakdev, Ahemdabad 
 
Primary Sponsor  
Name  Troikaa Pharmaceuticals Limited 
Address  Troikaa Pharmaceuticals Limited, Commerce House 1, Opp. Rajvansh Apartment, Satya Marg, Bodakdev, Ahemdabad 
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 Pvt. Ltd  Auriga Research pvt. Ltd, 3/15, Kirti Nagar Industrial Area
West
DELHI 		 9311234776

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  Curcuminoids Capsules  Six (06) Capsules containing 50 mg (as per label claim) of Curcuminoids each equal to a total dose of 300 mg of Curcuminoids (as per COA). 
Comparator Agent  Meriva-SR® Capsules   Five (05) Meriva-SR® 500 mg (as per label claim) capsules containing 59 mg curcuminoids each equal to a total dose of 295 mg of Curcuminoids (as per COA). 
 
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 and weighing at least 50 kg.
iv. Subjects must be of normal health as determined by medical history and physical examination, ECG, Chest X-ray (PA View) (valid if the X-ray is taken within one year), and laboratory tests performed within 28 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 Curcuminoids 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 below 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.
xi. Subjects who have taken over the counter or prescribed medications, including any enzyme modifying drugs within the last 14 days prior to the study.
xiii. Subject who have Smoking History of > 10 Cigarettes / day or Tobacco consumption > 4 packets / day.
xiv. Subjects who participated in any other clinical trial requiring repeated blood sampling or a blood donation program or blood loss of more than 350 ml, in the past three months (approx. 90 days) (This 350 mL includes the total blood loss that will occur during the study).
xv. Subject with clinically significant abnormal lab values / abnormal ECG or Chest X-ray (PA View).
xvi. Subject who has difficulty with donating blood.
xvii. Subject with positive Breath Alcohol Analysis or Urine Drug Screen (UDS) before admission.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
• To determine the absorption and assess the comparative bioavailability of single dose of test product Curcuminoids Capsules (a dose equal to 300 mg of Curcuminoids as per COA), Mfd. by Troikaa Pharmaceuticals Ltd., India, with reference drug Meriva-SR® capsules (a dose equal to 295 mg of Curcuminoids as per COA) of Thorne Research, Inc., USA, in healthy adult subjects, under fasting condition.
• To assess the intra subject variability of Curcuminoids Capsules.

 		 Pre dose sample of -10.00 hrs also be collected and Pre dose sample (00.00 hour ) will be collected within 30 minutes prior to drug administration and the post dose samples will be collected at 00.50, 0.75, 01.00, 01.50, 02.00, 02.50, 03.00, 04.00, 06.00, 08.00, 12.00, 16.00 and 24.00 hours respectively.  
 
Secondary Outcome  
Outcome  TimePoints 
• To assess the safety of the test and reference products on the basis of adverse events and/ or adverse drug reactions recorded in the study  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 10.00 hours post-dose and at the time of checkout (24.00 hrs).  
 
Target Sample Size   Total Sample Size="8"
Sample Size from India="8" 
Final Enrollment numbers achieved (Total)= "8"
Final Enrollment numbers achieved (India)="8" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   01/06/2016 
Date of Study Completion (India) 28/04/2017 
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)  

Curcumin [1, 7-bis (4-hydroxy-3-methoxyphenyl)-1, 6-heptadiene-3, 5-dionediferuloyl methane] , a major constituent of the yellow spice turmeric derived from the rhizomes of Curcuma spp., is one such polyphenol. Curcumin is the active ingredient in the traditional herbal remedy and dietary spice turmeric. Curcumin has a surprisingly wide range of beneficial properties, including anti-inflammatory, antioxidant, chemopreventive and chemotherapeutic activity.

Curcumin incorporates several functional groups. The aromatic ring systems, which are polyphenols are connected by two α,β-unsaturated carbonyl groups. The two carbonyl groups form a diketone. The diketone form stable enols or are easily deprotonated and form enolates, while the α,β-unsaturated carbonyl is a good Michael acceptor and undergoes nucleophilic addition.

Curcumin exhibits great promise as a therapeutic agent, and is currently in human clinical trials for a variety of conditions, including multiple myeloma, pancreatic cancer, myelodysplastic syndromes, colon cancer, psoriasis and Alzheimer’s disease

 
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