A bioavailability study of turmeric extracts in healthy human adult subjects under fasting conditions

Completed

Conditions: Bioavailability under fasting condition

Registration Number: CTRI/2014/02/004391

Lead Sponsor: Exodus Research Acer

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-âˆž.

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

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 16

Inclusion Criteria

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.

Exclusion Criteria

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.
q.Positive test for pregnancy for female subjects.

Study & Design

Study Type: BA/BE

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cmax,AUC_0-t and AUC_0-âˆž	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 Measures

Name	Time	Method
Safety and Tolerability	within 1 hr predose and Post dose at 24.00 hrs

Trial Locations

Locations (1): Semler Research Center Pvt Ltd
🇮🇳
Bangalore, KARNATAKA, India
Semler Research Center Pvt Ltd
🇮🇳Bangalore, KARNATAKA, India
Dr Lakshmikar B V
Principal investigator
080-43027100
drlakshmikar@semlerresearch.com