FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2014/02/004391 [Registered on: 10/02/2014] Trial Registered Prospectively
Last Modified On: 24/07/2014
Post Graduate Thesis  No 
Type of Trial  BA/BE 
Type of Study    
Study Design  Randomized, Crossover Trial 
Public Title of Study   A bioavailability study of turmeric extracts in healthy human adult subjects under fasting conditions 
Scientific Title of Study   A randomized, double blind, balanced, single center, two treatment, two period, two sequence, single dose, crossover relative bioavailability study of turmeric extracts in healthy human adult subjects, under fasting conditions. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
C-12-490  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr J Anuradha  
Designation  Principal Investigator 
Affiliation  Semler Research Center Pvt Ltd 
Address  Semler Research Center Pvt Ltd Sharon Hospital Campus 18 Tanmag Road Vinayagampatti Salem 636008

Salem
TAMIL NADU
636008
India 
Phone  0427-2404612  
Fax  0427-2404611  
Email  anuradha@semlerresearch.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Binu T Kuruvilla 
Designation  Assistant General Manager ( Research and Development) 
Affiliation  Arjuna Natural Extracts Limited 
Address  Arjuna Natural Extracts Ltd PBNo126 Bank Road Aluva Kochi Kerala

Ernakulam
KERALA
683101
India 
Phone  0484-2532404  
Fax    
Email  lab@arjunanatural.com  
 
Details of Contact Person
Public Query  
Name  Sooraj R Kartha 
Designation  Clinical trials manager 
Affiliation  Exodus Research Acer 
Address  Exodus Research Acer 283/A Thachil Road N.Kuthiathode Ernakulam Kerala

Ernakulam
KERALA
683594
India 
Phone  9847670997  
Fax    
Email  sooraj@eracro.in  
 
Source of Monetary or Material Support  
Arjuna Natural Extracts Ltd 
 
Primary Sponsor  
Name  Exodus Research Acer 
Address  Exodus Research Acer 283/A Thachil Road N.Kuthiathode Ernakulam Kerala India 683594 
Type of Sponsor  Contract research organization 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Lakshmikar B V  Semler Research Center Pvt Ltd  Semler Research Center Pvt Ltd P A Arcade No 21-22-23 Kodigehalli Main Road Sahakarnagar Bangalore-560092
Bangalore
KARNATAKA 		 080-43027100
91-80-43027142
drlakshmikar@semlerresearch.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Lifeline Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Bioavailability under fasting condition 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Curcuminoids 95%  Oral, single dose of 4X500mg capsules. Duration of therapy per period is 1 day. There are two periods in this study. 
Intervention  Turmeric extract formulation (80% curcuminoids)  Oral , single dose of 4X500mg capsules. Duration of therapy per period is 1 day. There are two periods in this study. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  a.Be healthy male or non-pregnant and non-lactating female 18 to 45 years of age, both ages inclusive.

b.Be healthy male or non-pregnant and non-lactating female of BMI within 18.50 to 24.99 Kg/ m2. Volunteers weighing less than 50 kg will not be enrolled.

c.Be able to communicate effectively with the study personnel.

d.Be a non consumer (user) of tobacco (not consumed tobacco in the past 6 months) or a mild or moderate consumer (user) of tobacco.

e.Have no evidence of underlying disease during screening medical history and whose physical examination is performed within 21 days prior to check in of period one.

f.Be medically healthy with clinically acceptable laboratory profiles, ECG (performed within 21 days prior to check-in of period one) and chest X-ray (performed within 6 months prior to check-in of period one).

g.Have given the written informed consent for voluntary participation in the study.

h.Be declared eligible to participate in the study by the investigator(s).

i.In addition, female volunteers selected for the study must:

i)Be using a medically acceptable form of birth control (such as foams, jellies, diaphragm, intra-uterine device (IUD) or abstinence) for the duration of the study as judged by the investigator(s) Or
ii)Be sterilized by surgical methods (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) at least 6 months back Or
iii)Have attained menopause at least 1 year back.
iv)And have a negative urine pregnancy test prior to check-in to the clinical facility.
 
 
ExclusionCriteria 
Details  a.Participation in any bioavailability, bioequivalence, Pharmacokinetic study or received an investigational drug within a period of 3 months prior to check in of period one.
b.History of drug abuse, or alcohol dependence or abuse.
c.History of any allergies (asthma, urticaria) including drug allergies.
d.Known hypersensitivity or allergy to curcuminoids or any of the excipients or related drugs
e.Severe consumer of tobacco.
f.Presence of a clinically significant disorder involving the cardiovascular,respiratory, renal, gastrointestinal, hepatic, immunologic, hematological, endocrine, or nervous system or psychiatric disease or other conditions that may interfere with the absorption, distribution, metabolism or excretion of study drug, or would place the subject at increased risk, as determined by the investigator.
g.Volunteers who have,
i.Systolic blood pressure less than 90 mm of Hg or more than 140 mm of Hg. Diastolic blood pressure less than 60 mm of Hg or more than 90 mm of Hg. Minor deviations 2-4 mm of Hg at check-in may be acceptable at the discretion of the physician /investigator.
ii.Pulse rate below 60 per minute or above 100 per minute.
iii.Respiratory rate below 15 or above 20 breaths per minute.
iv.Oral temperature less than 96.2F or more than 99.8F.
h.Clinical laboratory test values outside the acceptable reference range and when confirmed on re-examination deemed to be clinically significant.
i.Positive screening results for Hepatitis B, Hepatitis C, HIV or Syphilis.
j.Subject who has donated blood in the preceding 12 weeks prior to the check in of period one.
k.Already taking a nutritional supplement containing turmeric extracts and unable to discontinue using it 7 days prior to dosing.
l.Clinically significant illness during the 4 weeks prior to check-in of period one as determined by the investigators.
m.Use of any prescription drug for systemic action in the 28 days prior to check-in of period one or OTC, herbal medications drug 14 days prior to check-in of period one.
n.Positive result in breath analysis test for alcohol.
o.Positive urine drug screening results for any of the following: cocaine, THC, barbiturates, amphetamines, benzodiazepines, and morphine.
p.History of difficulty in swallowing tablets or capsules.
q.Positive test for pregnancy for female subjects.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pharmacy-controlled Randomization 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Cmax,AUC_0-t and AUC_0-∞  within 1hr predose, post dose 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 9.00, 12.00, 16.00 and 24.00 hours  
 
Secondary Outcome  
Outcome  TimePoints 
Safety and Tolerability  within 1 hr predose and Post dose at 24.00 hrs  
 
Target Sample Size   Total Sample Size="16"
Sample Size from India="16" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)
Modification(s)  		 16/06/2014 
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="0"
Days="18" 
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  

This study is a randomized, double blind, balanced, single center, two treatment, two period, two sequence, single dose, crossover relative bioavailability study of turmeric extracts in 16 healthy adult subjects under fasting condition. 

The primary objective of this study is to assess the relative bioavailability of curcuminoids from turmeric extracts. Study duration is from at least 11 hours prior to oral administration of 500mg x 4 capsules of test (turmeric extract formulation 80% curcuminoids)/ reference product (95% curcuminoids) up to 24 hours post dose in each period with at least 14 days washout between each consecutive treatment periods. The primary outcomes are Cmax, AUC0-t  and AUC0-∞.

 Bioequivalence between the two turmeric extracts under fasting condition will be concluded if the 90% confidence interval falls within the acceptance range of 80.00–125.00% for log-transformed pharmacokinetic parameters Cmax, AUC0-t & AUC0-∞ for curcuminoids. The test would be termed suprabioavailable if T/R ratio for (AUC0-t and AUC0-∞) is more than 1.

 
 
Close