| CTRI Number |
CTRI/2018/08/015403 [Registered on: 21/08/2018] Trial Registered Prospectively |
| Last Modified On: |
16/08/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative bioavailability/ bioequivalence study of Lutein formulations - Product C and Product D (Lutein 20 mg/capsule) supplementation in healthy, adult humans, after receiving high-fat, high-calorie breakfast. |
|
Scientific Title of Study
|
A double blind, balanced, randomized, two-treatment, single-period, single-dose, parallel, bioavailability/bioequivalence study of Lutein formulations - Product C and Product D (Lutein 20 mg/capsule) supplementation in healthy, adult human subjects under fed conditions. |
| Trial Acronym |
N/AP |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 037-CL-2018; Version 01: Dated 26/07/2018 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrS Suryudu MBBS FCD |
| Designation |
Principal Investigator |
| Affiliation |
AnaCipher Clinical Research Organisation |
| Address |
Mirra Kamshetty Mall (3rd and 4th Floor)
Ramanthapur
Rangareddi
ANDHRA PRADESH
500013
India |
| Phone |
04027032631 |
| Fax |
|
| Email |
sabbani.suryudu@anacipher.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrS Suryudu MBBS FCD |
| Designation |
Principal Investigator |
| Affiliation |
AnaCipher Clinical Research Organisation |
| Address |
Mirra Kamshetty Mall (3rd and 4th Floor)
Ramanthapur
Rangareddi
ANDHRA PRADESH
500013
India |
| Phone |
04027032631 |
| Fax |
|
| Email |
sabbani.suryudu@anacipher.com |
|
Details of Contact Person
Public Query
|
| Name |
M Rambabu M Pharm Pharmaceutics |
| Designation |
General Manager |
| Affiliation |
AnaCipher Clinical Research Organisation |
| Address |
Mirra Kamshetty Mall (3rd and 4th Floor)
Ramanthapur
Rangareddi
ANDHRA PRADESH
500013
India |
| Phone |
|
| Fax |
|
| Email |
maddela.rambabu@anacipher.com |
|
|
Source of Monetary or Material Support
|
| OmniActive Health Technologies Ltd.,
India |
|
|
Primary Sponsor
|
| Name |
Mr Abhijeet Morde |
| Address |
OmniActive Health Technologies Ltd,
A-10 Road No 1, Wagle Industrial Estate,
Thane (W)-400 064,
Maharashtra, India |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr S Suryudu |
AnaCipher Clinical Research Organisation |
Mirra Kamshetty Mall (3rd and 4th Floor)
Ramanthapur
Rangareddi
ANDHRA PRADESH |
04027032631
sabbani.suryudu@anacipher.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maarg Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human Subjects |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
FloraGLO Lutein 10% CWS/S-TG beadlets |
FloraGLO Lutein 10% CWS/S-TG beadlets procured from DSM Nutritional Products Inc. France and the finished product FloraGLO Lutein beadlets (Lutein 20 mg/capsule) filled in capsule by OmniActive Health Technologies Ltd., India. |
| Intervention |
Lutemax 2020 10% beadlets (Lutein 20 mg/capsule) |
Lutemax 2020 10% beadlets (Lutein 20 mg/capsule) of OmniActive Health Technologies Ltd., India |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Healthy, adult, human subjects within the age range of ≥ 21 to 55 years.
2.A body mass index between 20 to 27 kg/m2.
3.Participation is truly voluntary.
4.Subjects should avoid lutein and zeaxanthin-Yellow and green rich vegetables and fruits such as mangoes, tangerines, oranges, asparagus, broccoli, butternut squash, cilantro, collards, orange pepper, parsley, papaya, peas, pistachio, romaine lettuce, scallions, zucchini, kale, Brassica oleracea, spinach, carrots, corn, tomatoes, nectarines, and peaches etc. during the study period and restricted to ≤1-2 servings per day at least for a week before dosing
5.Subjects should exclude eggs from diet during the period of the study.
6.Non-smokers and non-alcoholics.
7.Given written informed consent to participate in the study.
8.Absence of disease markers of HIV 1 & 2, hepatitis B & C virus.
9.Absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history, physical examination and systemic examination during the screening.
10.A normal 12-lead ECG.
11.A normal chest X-ray (PA view) done within past 6 months.
12.Compliance with the requirement of the entire protocol.
13.For female subjects:
•Female of childbearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence: or
•Postmenopausal for at least 1 year, or
•Surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy has been performed on the subject). |
|
| ExclusionCriteria |
| Details |
1.Institutionalized subjects.
2.History or evidence of hypersensitive to Lutein or Zeaxanthin.
3.History or evidence of chronic diseases such as diabetes, hypertension, liver disorders, kidney disorders, pulmonary disease or infections, cardiovascular disease, pancreatic disease, infectious diseases, dermatological problems, arthritis and any cancer.
4.History of hypo and hyperthyroidism.
5.Presence of alarm signs or symptoms, including fever, gastrointestinal bleeding, unintentional weight loss, anemia, dysphagia, or abdominal mass.
6.History of milk, gluten allergies or other known food intolerances and or any food allergies.
7.History of significant systemic diseases, seizures, psychiatric disorders, neurological disorders, depression, or mental illness and allergic rash.
8.Habit of consuming high caffeine (more than 5 cups of coffee or tea/day) consumption.
9.History of difficulty with donating blood or difficulty in accessibility of veins.
10.History of addiction to any recreational drug or drug dependence.
11.Donation of blood (one unit or 350 mL) within 90 days prior to study check-in.
12.Participation in any clinical study within the past 90 days.
13.Receipt of any prescription drugs or over-the-counter drugs (e.g.: cold preparations antacid preparations and natural products used for therapeutic benefits) within 30 days prior to screening.
14.Current use of vitamin or multivitamin supplements providing carotenoids (e.g., supplements including lutein, beta-carotene, lycopene, or beta-cryptoxanthin).
15.History of dehydration from diarrhea, vomiting or any other reason within a period of 24.0 hours prior to check-in of study period.
16.An unusual or abnormal diet within 48.00 hours prior to check-in of study period, for whatever reason e.g. because of fasting due to religious reasons.
17.Received pharmacological agents known to significantly induce or inhibit drug metabolizing enzymes within 14 days of the start of the study.
18.Consumption of food and beverages containing xanthine (chocolates, tea, coffee or cola drinks) for at least 48.00 hours prior to check-in of study period.
19.Consumed grapefruit and grapefruit like citrus fruit (mosumbi/sweet lime) or juice within the 7 days prior to check-in of study period.
20.Positive results for drugs of abuse (benzodiazepines, opioids, amphetamines, cannabinoids, cocaines and barbiturates) in urine during the check-in of study period.
21.Use of macular carotenoids supplementation, omega 3 fatty acids, alpha lipoic acid or fatty acid supplements within 14 days of the start of the study.
22.Current use or a history of use (i.e., within 60 days of the Screening visit) of lutein and/or zeaxanthin supplements.
23.Positive results for alcohol breathe analysis during the check-in of study period.
24.Female volunteers demonstrating positive pregnancy test.
25.Female volunteers who are currently breast-feeding or who are likely to become pregnant during the study.
26.Female volunteers who have used implanted or injected hormonal contraceptives anytime during the 6 months prior to study or used hormonal contraceptives within 30 days before dosing. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the bioavailability/ bioequivalence of lutein from a single oral dose of lutein formulations - Product C and Product D (Lutein 20 mg/ capsule) supplementation in healthy, adult human subjects under fed conditions. |
Fourteen (14) blood samples of 1 x 6 mL will be collected in pre-labelled plain vacutainer during study.
Three pre-dose blood samples at -48.00, -24.00 hours [with a window period of ± 30 minutes) and 0.00 hours (within 45 minutes before dosing) will be collected before dosing.
Single venous blood sample will be withdrawn at 2.00, 4.00, 6.00, 8.00, 10.00, 12.00, 16.00, 20.00, 24.00, 48.00 and 72.00 hours post-dose on day 0 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The following parameters will be determined from the serum baseline corrected and baseline-uncorrected Lutein data using Phoenix WinNonlin 6.4 or higher version.
Primary parameters: Cmax and AUC0-72h
Secondary parameters: AUC0-12h, AUC0-24h, AUC0-48h, AUC0-t, AUC0-ï‚¥, Tmax, Kel, t1/2 |
Fourteen (14) blood samples of 1 x 6 mL will be collected in pre-labelled plain vacutainer during study.
Three pre-dose blood samples at -48.00, -24.00 hours [with a window period of ± 30 minutes) and 0.00 hours (within 45 minutes before dosing) will be collected before dosing.
Single venous blood sample will be withdrawn at 2.00, 4.00, 6.00, 8.00, 10.00, 12.00, 16.00, 20.00, 24.00, 48.00 and 72.00 hours post-dose on day 0 |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
21/08/2018 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="7" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Publication of the results of the study, whether in whole or in part, shall be within the sole and absolute discretion of the sponsor (OmniActive Health Technologies Ltd).
CRO (AnaCipher Clinical Research Organisation) shall not be entitled to publish any of the data or information arising during or out of the provision of the services without the prior written consent of sponsor. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a double blind, balanced,
randomized, two-treatment, single-period, single-dose, parallel, comparative
bioavailability study of Lutein formulations - Product C and Product D (Lutein 20
mg/capsule) supplementation in healthy, adult human subjects under fed
conditions.
Each subject enrolled will
participate in single period study in accordance with the randomisation
schedule, as per the randomization schedule, under fed conditions and subjects
will be dosed in parallel manner either Product (C) or Product (D) ‘treatment’
in the single period.
As
it is a single-period, parallel design, washout period is not applicable for
this study. The total clinical duration of the study is approximately 07 days. |