None listed
Conditions
Interventions
Intervention1: BCM-95 (500 mg): Curcumin Capsule of Plant Lipids manufacturer (Test medicine) or one of the two Reference products manufactured by Arjuna. Frequency of INTERVENTION is 19 times, Durati
Sponsors
Plant Lipids P Limited
Eligibility
Inclusion criteria
Inclusion criteria: b) Volunteer having Body Mass Index of 18.5 to 24.9 Kg/m2 (Inclusive). c) Volunteer with no evidence of underlying disease during the pre-study screening, medical history, physical examination and laboratory investigations performed within 21 days prior to commencement of the study d) Volunteer whose pre-study screening laboratory tests are either normal or within acceptable limits or are considered by the Investigator to be of no clinical significance with respect to his participation in the study. e) Volunteer with negative test for alcohol and drugs of abuse, hepatitis B & C and who is negative or non reactive for antibodies to HIV 1 and 2. f) Volunteer having a 12 lead ECG recording within normal limits. g) Volunteer with normal chest X-ray taken within 6 months before the day of dosing. h) Volunteer will be available for the entire study period and is capable of understanding and communicating with the investigators and clinical study facility staff.
Exclusion criteria
Exclusion criteria: a) Volunteer who is allergic to Curcumin or any component of the formulation and to any other related drug. b) Volunteer with history or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological or psychiatric disease. d) History of clinically relevant allergy (except for untreated, asymptomatic, seasonal allergies at time of dosing) or any allergic reactions to any drugs e) History of Vascular collapse f) Volunteer who is scheduled for surgery within 7 days after study completion. g) Volunteer who, through completion of any other clinical study or otherwise would have donated in excess of 350 mL of blood in the last 90 days. h) Volunteer who has taken prescription medication or over-the-counter products (including vitamins and products from natural origin) within 14 days prior to administration of IP, including topical medication meant for systemic absorption i) Volunteer who was hospitalized within 28 days prior to administration of the study medication. j) Volunteer with history of difficulty in swallowing k) Volunteer who has unsuitable veins for repeated venipuncture l) Any abnormal laboratory value or physical finding which may interfere with the interpretation of test results or cause a health hazard for the volunteer if he participates in the study m) Volunteer who has: ô??? Systolic blood pressure less than 90 mm of Hg or more than 150 mm of Hg Diastolic blood pressure less than 60 mm of Hg or more than 94 mm of Hg
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the single-dose oral bioavailability of Cureit capsule (500 mg) with BCM-95 (500 mg) and Meriva (500 mg) Capsule in healthy human adult male subjects under fasting conditions.Timepoint: A total of 19 (1Ã?6 mL) blood samples will be collected from each subject. The pre-dose sample (1Ã?6 mL) will be collected within 01.00 hour before dosing. The post-dose samples (1Ã?6 mL) will be collected at 00.25, 00.50, 00.75, 01.00, 01.25, 01.50, 01.75, 02.00, 02.25, 02.50, 02.75, 03.00, 04.00, 06.00, 08.00, 10.00, 12.00, 24.00 hours after dosing. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objective of this study is to monitor the safety and tolerability of a single oral dose of Cureit capsule (500 mg) when administered in healthy human adult male subjects under fasting conditionsTimepoint: The post-dose samples (1Ã?6 mL) will be collected at 00.25, 00.50, 00.75, 01.00, 01.25, 01.50, 01.75, 02.00, 02.25, 02.50, 02.75, 03.00, 04.00, 06.00, 08.00, 10.00, 12.00, 24.00 hours after dosing. | — |
Countries
India
Contacts
Public ContactJeevan
MG DIAGNOSTIC & IMAGING CENTRE
Outcome results
None listed