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Bio availability study of LZK-10 in comparison with unformulated Lutein

A randomized, single-dose, double-blind, 6-way, 6-sequence, crossover, study to assess the bioavailability of Lutein supplementations (LZK-10, 250 mg, 500 mg and 1000 mg) in comparison with normal unformulated Lutein supplementations in healthy volunteers.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/06/034084
Enrollment
16
Registered
2021-06-08
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: LZK-10 â??250 mg : Single day Oral Administration of Single dose of LZK-10 - 250 mg capsules Intervention2: LZK-10 â??500 mg: Single day Oral Administration of Single dose of LZK-10 - 5

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 quercetin containing food 2 days prior to screening 2. Pregnant or lactating women. 3. Subjects having symptoms of viral infection, including COVID-19 infection 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 concentrations of LZK-10, Lutein supplementations (250 mg, 500 mg and 1000 mg) in comparison with unformulated Leutin supplementations (250 mg, 500 mg and 1000 mg)Timepoint: Day 1 (Period 1), Day 11 (Period 2) Day 21 (Period 3), Day 31 (Period 4) , Day 41 (Period 5), Day 51 (Period 6)—

Secondary

MeasureTime frame
Safety and tolerability of the LZK-10, Lutein supplementations in comparison to unformulated Leutin supplementsTimepoint: Day 1 (Period 1), Day 11 (Period 2) Day 21 (Period 3), Day 31 (Period 4) , Day 41 (Period 5), Day 51 (Period 6)—

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