None listed
Conditions
Interventions
Intervention1: Turmeric extract formulations: Turmeric extract 500 mg Hard gelatine capsules of M/s Arjuna Extract Limited, Kerala.
Control Intervention1: Turmeric extract: Turmeric extract 500 mg Har
Sponsors
Arjuna Natural Extracts Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1 Subject who are able and ready to provide written informed consent. 2 Subjects must be healthy human male subjects within 18-40 years of age (both inclusive), weighing at least 50 kg. 3 Subjects should be having Body Mass Index (BMI) in the range 18.5-30.0 kg/m2. 4 Subjects must be of normal health 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. 6 Availability of the subject for the entire study period and willingness to adhere to the protocol requirements as evidenced by written informed consent.
Exclusion criteria
Exclusion criteria: 1 Subjects incapable of understanding the informed consent process or not ready to sign informed consent. 2 Subjects with significant history of hypersensitivity to turmeric or turmeric extracts or curcuminiods or to any drugs. 3 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 curcuminoidsto undesired effects. - 4 Subjects with active peptic ulceration or a history of peptic ulceration. 5 Subject with resting hypotension (BP 139 /89). 6 Subject with Pulse rate below 50/ min. and above 99/min. 7 Subjects with or prior history of clinically significant, Cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease. 8 Subjects with a history of MI, Stroke, Peripheral Arterial Disease, GI Bleeding, Hepatic-Impairment, Renal Impairment, Epilepsy and Intracranial hemorrhage. 9 Subjects with a history of known food allergy. 10 Subjects who have suffered any illness or who have been hospitalized within the last 4 weeks preceding the start of the study. 11 Use of an investigational device or investigational drug within 90 days or 6 half-lives. 12 Subjects who have taken over the counter or prescribed medications, including any enzyme modifying drugs within the last 14 days prior to the study. 13 Subject who have a History of alcoholism, drug abuse or Smoking. 14 Subjects who participated in any other clinical study 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). 15 Subject with clinically significant abnormal lab values / abnormal ECG / abnormal Chest X-ray (PA View). 16 Subject who has difficulty with donating blood.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary (Pharmacokinetic) objective The primary objective of this study is to assess the curcuminoids in blood plasma after oral administration of turmeric extract formulations in 18 healthy human adult male subjects, under fasting conditions.Timepoint: 00.00, 00.25, 00.50, 00.75, 01.00, 01.50, 02.00, 02.50, 03.00, 04.00, 05.00, 06.00, 08.00, 09.00, 12.00, 16.00 and 24.00 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary (Safety) objective The secondary objective of this study is to monitor the safety and tolerability of a single dose of turmeric extract formulations in 18 healthy human adult male subjects, under fasting conditions.Timepoint: Day 0 and Day 37 | — |
Countries
India
Contacts
Public ContactDr Deepa Subramanian
Arjuna Natural Extracts Limited
Outcome results
None listed