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A comparative Clinical study to evaluate the Bioavailability of BSW3510 with normal unformulated active ingredients.

A randomised, single-dose, double-blind, 4-way crossover, 4 sequence study to assess the bioavailability of BSW3510 in comparison with normal unformulated active ingredient supplementation in healthy volunteers.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/08/020871
Enrollment
16
Registered
2019-08-23
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

None listed

Interventions

Intervention1: BSW3510: Oral Administration of Single dose of BSW3510 Control Intervention1: IP 2: Oral Administration of Single dose of IP 2 Control Intervention2: IP 3: Oral Administration of Single

Sponsors

Akay Flavours and Aromatics Private Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1 Subjects who are willing to give their written informed consent and comply with the protocol requirements. 2 Females of child bearing age, agree to use approved birth control methods during the study, and have negative urine pregnancy test (UPT) at screening 3 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 turmeric containing food 2 days prior to screening 2 Pregnant or lactating women. 3 Subjects with known hypersensitivity to the investigational products. 4 Subjects who have participated in any clinical trial in the past 1 month. 5 Any subjects found to have entered in to the study in violation of this protocol or if the subject is uncooperative during the study. 6 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
Estimate the concentrations of BSW3510 in comparison with normal unformulated supplementationTimepoint: Day 0, Day 1, Day 11, Day 21, Day 31—

Secondary

MeasureTime frame
Maximum plasma concentrations (Cmax) of BSW3510 in comparison with normal unformulated supplementation Area under the plasma concentrations versus time curve (AUC) of BSW3510 in comparison with normal unformulated supplementation The safety and tolerability of BSW3510 in comparison with normal unformulated supplementationTimepoint: Day 0, Day 1, Day 11, Day 21, Day 31—

Countries

India

Contacts

Public ContactJestin V Thomas

Leads Clinical Research and Bio Services Private Limited

jestin.leadsclinbio@gmail.com9845125293

Outcome results

None listed

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