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A comparative Bioavailability study in Healthy Subjects

A randomized, single-dose, double-blind, active-controlled, 2-way crossover, study to assess the bioavailability of bisdemethoxycurcumin (BDMC) of a standardized turmeric extract (REVERC3) in healthy volunteers.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/05/042653
Enrollment
16
Registered
2022-05-19
Start date
Unknown
Completion date
Unknown
Last updated
2022-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: REVERC3 10000mg: Single Day Oral application of single dose of 1000mg REVERC3 Control Intervention1: Regular turmeric extract 1000 mg: Single Day Oral application of single dose of 1000

Sponsors

Vidya Herbs Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Healthy volunteers who are not involved in any regular medication or supplementation. 2.Subjects who are willing to give their written informed consent and comply with the protocol requirements. 3.Females of childbearing age, agree to use approved birth control methods during the study, and have negative urine pregnancy test (UPT) at screening 4.Subject understands the study procedures, is ready to comply and provide signed informed consent form (ICF) to participate in the study

Exclusion criteria

Exclusion criteria: 1.Subjects who have consumed curcumin (turmeric) containing food 2 days prior to screening 2.Subjects having symptoms of viral infection, including COVID-19 infection 3.Pregnant or lactating women. 4.Subjects with known hypersensitivity to the investigational products. 5.Subjects who have participated in any clinical trial in the past 1 month. 6.Any subjects found to have entered into the study in violation of this protocol or if the subject is uncooperative during the study. 7.Any other condition that in the opinion of the investigator that does not justify the subjectâ??s participation in the trial.

Design outcomes

Primary

MeasureTime frame
Plasma concentrations of BDMC and curcuminTimepoint: Pre-dose sample within 1 hour before dosing. Post-dose samples will be collected at 30 min, 60 min, 90 min, 2, 4, 6 and 12.00 (hr:min)—

Secondary

MeasureTime frame
(Cmax), (tmax), (t1/2) ,(Kel)]Timepoint: Pre-dose sample within 1 hour before dosing. Post-dose samples will be collected at 30 min, 60 min, 90 min, 2, 4, 6 and 12.00 (hr:min)—

Countries

India

Contacts

Public ContactJestin V Thomas

Leads Clinical Research and Bio Services Pvt. Ltd

jestin.leadsclinbio@gmail.com9845125293

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026