A randomized, pilot double blind, single center, one period, single dose, four arm bio-availability study of Curcumin formulations in 28 healthy human adult male subjects, under fasting conditions.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Tata Chemicals Ltd
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- To determine the bioavailability of curcumin in respective Curcuminoid based formulations.
Study Overview
Brief Summary
Randomised, pilot, double blind,one period, four arm bioavailability studies is considered to be of the highest standards for assessment of efficacy and safety of a studymedication; accordingly the same design has been used for this study. Healthy volunteers to will berecruited to this study. This will be accomplished by conducting Laboratory test and physicalexamination by the Principal Investigator. Once all the parameters are found to be normal thesubjects will be recruited to this study. This will be 1 period, 1 arm study. The volunteers will be admitted in the facility 11 hoursprior to dosing and will leave the facility 24 hours after the dosing.
The objective of this study is to determine the bioavailability of curcummin in respective curcuminoid based formulations in 28 healthy human adults male subjects under fasting conditions andalso to monitor the safety and tolerability of a single dose of curcummin formulations.
Type of study: Randomised, pilot, double blind, one period, four arm bioavailability study.
Study groups
Group І –Turmeric Extract 95%
Group II –Sustential Curcumin powder
Group III –Curcuminoid-Green tea extract formulation
Group IV –Curcumin Powder
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 40.00 Year(s) (—)
- Sex
- Male
Inclusion Criteria
- •1.Subjects must be healthy human male subjects.
- •2.Age should be between 18-40 years of age (both inclusive), weighing at least 50 kg.
- •3.Subject who are ready to provide written informed consent and should be willing to be available throughout the study duration and should follow the guidelines mentioned in the protocol.
- •4.Subjects with no evidence of underlying disease during the pre-study screening.
- •They must be healthy as determined by medical history and physical examination, ECG, Chest X-ray (PA View) and laboratory tests performed within 21 days prior to the commencement of the study.
- •5.Subjects whose screening laboratory values are within normal limits or considered by the physician / Principal Investigator to be of no clinical significance.
Exclusion Criteria
- •1.Subjects who are allergic to turmeric or its extracts or curcuminoids or any food or other drugs.
- •2.Subject with resting hypotension (BP <90 /60) or hypertension (BP >140 /90) and pulse rate below 50/min and more than 100/min.
- •3.Subject with or a prior history or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, musculoskeletal or psychiatric disease or who has been hospitalized or underwent surgery within the last 4 weeks prior to in-housing.
- •4.Subjects with a history of MI, Stroke, Peripheral Arterial Disease, GI Bleeding, Hepatic-Impairment, Asthma, Renal Impairment, Epilepsy and Intracranial hemorrhage.
- •5.Subjects who have taken over the counter or prescribed medications including any enzyme modifying drugs within the last 14 days prior to the study.
- •6.Subject who have a History of alcoholism, drug abuse or Smoking.
- •7.Subjects who are hypersensitive to Heparin 8.Subjects who participated in any other clinical study in the past three months.
- •10.Subject who has difficulty with donating blood.
- •11.Subject with history of difficulty in swallowing.
- •12.Subject who has unsuitable veins for repeated venipuncture.
Outcomes
Primary Outcomes
To determine the bioavailability of curcumin in respective Curcuminoid based formulations.
Time Frame: 0:00, 0:25, 0:50, 0:75, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24hrs.
Secondary Outcomes
- The secondary objective of this study is to monitor the safety and tolerability of a single dose of curcumin formulations in 28 healthy human adult male subjects, under fasting conditions.(Day 0 and Final day)