None listed
Conditions
Interventions
Intervention1: Arm 1: Test Formulation I 120:20 mix
Arm2 : Test Formulation II
30:5 mix: administered orally single dose
Control Intervention1: Curcuminoid formulation 500mg dose: administered ora
Sponsors
FFF Bio Works LLP
Eligibility
Inclusion criteria
Inclusion criteria: 1.Subjects must be healthy human male subjects. 2.Age should be between 18-65 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 5. They must be healthy as determined by medical history and physical examination and laboratory tests performed within 14 days prior to the commencement of the study. 6.Subjects whose screening laboratory values are within normal limits or considered by the physician / Principal Investigator to be of no clinical significance.
Exclusion criteria
Exclusion criteria: 1. Subjects who are allergic to turmeric or its extracts or curcuminoids or lutein or any food or other drugs. 2. Subject with resting hypotension (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. 9. Subject with clinically significant abnormal lab values/ abnormal ECG / abnormal Chest X-ray (PA View). 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the bioavailability of curcuminoids and lutein in respective Curcuminoid and Lutein combination based formulationsTimepoint: 0:00 min, 30 min, 1, 2, 3, 4, 6 and 24hrs. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objective of this study is to monitor the safety and tolerability of a single dose of Curcuminoid and Lutein combination formulations in healthy human adult male subjects, under fasting conditions.Timepoint: 0 hr to 24 hrs | — |
Countries
India
Contacts
Public ContactMr Jayaram M
FFF Bio Works LLP
Outcome results
None listed