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A comparative Bioavailability study of CCL in Healthy Volunteers

A randomized, single-dose, double-blind, 4-way, 4â??sequence crossover, study to assess the bioavailability and pharmacokinetics of CCL formulations in comparisons with unformulated bioactives in healthy volunteers

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/07/026856
Enrollment
16
Registered
2020-07-28
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: CCL 20: Single day Oral Administration of Single dose of CCL 20 Intervention2: CCL 10: Single day Oral Administration of Single dose of CCL 10 Control Intervention1: Bioactive 1: Single

Sponsors

Akay Natural Ingredients Pvt Ltd
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 food containing any ingredients of the formulation within 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 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 study

Design outcomes

Primary

MeasureTime frame
The primary objective of the study is to assess the bioavailability of CCL-20, 500mg incomparison with CCL-10 and unformulated BioactivesTimepoint: Day 1 (period 1), Day 11 (Period 2) Day 21 (period 3), Day 31 (Period 4)—

Secondary

MeasureTime frame
The secondary objective of the study is to assess the safety of CCL-20, 500 mg in comparison with CCL-10 and unformulated BioactivesTimepoint: Day 1 (period 1), Day 11 (Period 2) Day 21 (period 3), Day 31 (Period 4)—

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