None listed
Conditions
Interventions
Intervention1: Test Product â??II (T2) : Cookies with BioTurCuSolâ?¢ 20 AS: Single dose oral administration of 10 Cookies X 200 mg of Curcuminoids, Curcuminoids 20% Aqueous Suspension of Drishtee Natu
Sponsors
Drishtee Naturals Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: i. Subject who are able and ready to provide written informed consent. ii. Subjects must be healthy male human beings within 18-45 years of age (both inclusive). iii. Subjects should be having Body Mass Index (BMI) in the range 18.5-30 kg/m2, weighing at least 50 kg. iv. Subjects must be of normal health as determined by medical history, physical examination, ECG and laboratory tests performed within 21 days prior to the commencement of the study. v. 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: • Subjects incapable of understanding the informed consent process or not ready to sign informed consent. • Subjects with significant history of hypersensitivity to Curcuminoids formulations or any ingredients of the formulation or any related products as well as severe hypersensitivity reactions (like angioedema) to any drugs. • 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 drugs or known to potentiate or predispose to undesired effects. • Subjects with active peptic ulceration or a history of peptic ulceration. • Subject with resting hypotension (BP 139 /89). • Subject with Pulse rate 50/ min. and above 99/min. • Subjects with or prior history of clinically significant, Cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease. • Subjects with a history of MI, Stroke, Peripheral Arterial Disease, GI Bleeding, Hepatic-Impairment, Renal Impairment, Epilepsy and Intracranial hemorrhage. • Subjects with a history of known food allergy. • Subjects who have suffered any illness or who have been hospitalized within the last 4 weeks preceding the start of the study. • Subject who has difficulty with donating blood. • Subject with positive Breath Alcohol Analysis before admission.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the bioavailability of single oral dose of two Curcuminoids formulations incorporated in Cookies (each containing 200mg of Curcuminoids x 10 cookies) of Drishtee Naturals Private Limited, India with two marketed Curcuminoids formulations incorporated in Cookies (each containing 200mg of Curcuminoids x 10 cookies) in 20 Healthy adult human male subjects under fasting conditions.Timepoint: Time-Points for bioavailability estimation are -Pre dose (00.00 hour) sample will be collected within 02 hours prior to Investigational Product administration and the post dose samples will be collected at 00.25, 00.50, 00.75, 01.00, 01.25, 01.50, 01.75, 02.00, 02.50, 03.00, 04.00, 05.00, 06.00, 08.00, 10.00, 12.00 and 24.00 hours respectively. | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor adverse events and assess safety and tolerability of Curcuminoids formulations in Cookies under fasting condition.Timepoint: Vital signs - sitting blood pressure, radial pulse rate, oral temperature will be assessed at admission, prior to dosing (00.00 hrs) and at 02.00, 06.00 and 12.00 hours post-dose and at the time of checkout (24.00 hrs). | — |
Countries
India
Contacts
Public ContactDr Manoj Karwa
Drishtee Naturals Pvt. Ltd.
Outcome results
None listed