Absorption and availability of NCT023 extract in blood in healthy volunteers
- Registration Number
- CTRI/2023/10/058565
- Lead Sponsor
- isarga Biotech Pvt. Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 14
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.
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
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 1.AUC0-8, t1/2, tmax of Curcuminoids from NCT023 extract vs comparator 1 & comparator 2. <br/ ><br>2. AUC0-tlast & Cmax of ar-turmerone from NCT023 extract <br/ ><br>3. AUC0-8, t1/2, tmax of ar-turmerone from NCT023 extract <br/ ><br>4. Adverse events <br/ ><br>Timepoint: 0, 0.50, 1, 2, 4, 5, 6, & 8 h post study product administration