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A study to assess the bio availability of BCO-5 in comparison with unformulated extracts in healthy volunteers.

A randomized,single-dose,double-blind,3 way,3-sequence,crossover,study to assess the bioavailabilty of BCO-5 in comparison with unformulated extracts in healthy volunteers.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/11/047533
Enrollment
20
Registered
2022-11-22
Start date
Unknown
Completion date
Unknown
Last updated
2023-01-09

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

Conditions

None listed

Interventions

Intervention1: BCO-5: Single day Oral Administration of Single dose of BCO-5 Control Intervention1: Unformulated Ingredient I: Single day Oral Administration of Single dose of Unformulated Ingredient

Sponsors

Akay Natural Ingredients Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.BMI between 18-25 kg/m2 (inclusive) 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 having symptoms of viral infections in the last 2 weeks 2.Pregnant or lactating women 3. History of Irritable bowel syndrome, malabsorption or gastrointestinal abnormalities which may affect drug absorption, duodenal ulcer or gastric ulcer, gastritis, Kidney disease, kidney stones, cardiac conditions, Recent blood donation (within 1 month),Current smoker or has quit smoking within last 3months, Alcoholism and/or drug abuse, or heavy drinkers, Immunodeficiency disease (e.g., human immunodeficiency virus infection,Allergy, medication or supplement use that influences the immune system 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 in to 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
Change in Plasma Concentration With BCO-5,Unformulated Ingredient I, and Unformulated Ingredient II administrationsTimepoint: Day 1 (Period I) and Day 11 (Period II) and Day 21 (Period III)—

Secondary

MeasureTime frame
The safety and tolerability BCO-5 in comparison with unformulated ingredient I and unformulated ingredient II supplementationTimepoint: Day 1 (Period I), Day 11 (Period II) and Day 21 (Period III)—

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