None listed
Conditions
Interventions
Intervention1: NCT023 extract: NCT023 extract will be administered to subjects in a dose of 8 gm as single dose
Control Intervention1: Curcuma longa extract (95% curcuminoids) with Piper longum extrac
Sponsors
Nisarga Biotech Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy male and female subjects 2. Ability to communicate adequately with the investigator 3. Subjects who are ready to provide written informed consent and who are ready to willingly participate and follow the protocol requirements of the clinical study.
Exclusion criteria
Exclusion criteria: 1. Any history or presence of clinical relevance of cardiovascular, neurological, musculoskeletal, hematological, hepatic, gastrointestinal, renal, pulmonary, endocrinological, metabolism or psychiatric disease, any type of porphyria. 2. Presence or history of malabsorption or any gastrointestinal surgery except appendectomy or except herniotomy. 3. Subjects who have participated to any drug research within the last one month before the first drug administration. 4. Subjects suspected to have a high probability of non-compliance to the study procedure and/or completion of the study according to the investigator’s judgement. 5. History of allergic response to Curcuma longa. 6. Subjects who have any chronic disease which might interfere with absorption, distribution, metabolism or excretion of the drug. 7. History of drug and alcohol abuse. 8. History of difficulty in swallowing. 9. Pregnant and Lactating females 10. Subjects having any medical or surgical condition that would require immediate medical or surgical intervention at the time of screening 11. Subjects having immune compromised status like HIV, Hepatitis, Tuberculosis and Cancer etc. 12. Other conditions, which in the opinion of the investigators makes the patient unsuitable for enrolment or could interfere in adherence to of the study protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC0-tlast and Cmax of Curcuminoids from NCT023 extract vs comparator 1 and comparator 2Timepoint: 0, 0.50, 1, 2, 4, 5, 6, and 8 h post study product administration | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. AUC0-8, t1/2, tmax of Curcuminoids from NCT023 extract vs comparator 1 & comparator 2. 2. AUC0-tlast & Cmax of ar-turmerone from NCT023 extract 3. AUC0-8, t1/2, tmax of ar-turmerone from NCT023 extract 4. Adverse events Timepoint: 0, 0.50, 1, 2, 4, 5, 6, & 8 h post study product administration | — |
Countries
India
Contacts
Public ContactDr Sanjay Tamoli
Target Institute of Medical Education and Research Pvt. Ltd.
Outcome results
None listed