| CTRI Number |
CTRI/2024/04/065104 [Registered on: 02/04/2024] Trial Registered Prospectively |
| Last Modified On: |
01/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A comparative Bioavailability study of FC-AK-23 in Healthy Human Volunteers. |
|
Scientific Title of Study
|
A Comparative, Single-Dose, 2-Way Crossover, 6 Sequence Study to Assess the Bioavailability of Formulated Caffeine (FC-AK-23) in Comparison with Normal Unformulated Caffeine (UFC-AK-23) and A Commercial Caffeine Supplementation (CC-AK-23) in Healthy Volunteers. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| LCBS-BA-127 Version 1.0 dated 18-Jan-2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jestin V Thomas |
| Designation |
Director |
| Affiliation |
Leads Clinical Research and Bio Services Pvt. Ltd |
| Address |
Department of Clinical Research, No.9, 1st Floor, Mythri Legacy, Chelekere Main Road, Kalyan Nagar
Bangalore
KARNATAKA
560043
India |
| Phone |
9845125293 |
| Fax |
|
| Email |
jestin.leadsclinbio@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jestin V Thomas |
| Designation |
Director |
| Affiliation |
Leads Clinical Research and Bio Services Pvt. Ltd |
| Address |
Department of Clinical Research, No.9, 1st Floor, Mythri Legacy, Chelekere Main Road, Kalyan Nagar
KARNATAKA
560043
India |
| Phone |
9845125293 |
| Fax |
|
| Email |
jestin.leadsclinbio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jestin V Thomas |
| Designation |
Director |
| Affiliation |
Leads Clinical Research and Bio Services Pvt. Ltd |
| Address |
Department of Clinical Research, No.9, 1st Floor, Mythri Legacy, Chelekere Main Road, Kalyan Nagar
KARNATAKA
560043
India |
| Phone |
9845125293 |
| Fax |
|
| Email |
jestin.leadsclinbio@gmail.com |
|
|
Source of Monetary or Material Support
|
| Akay Natural Ingredients Pvt. Ltd,Malaidamthuruthu P.O Ernakulam, Kerala 683561, India |
|
|
Primary Sponsor
|
| Name |
Akay Natural Ingredients Pvt. Ltd |
| Address |
Malaidamthuruthu P.O Ernakulam, Kerala 683561, India |
| Type of Sponsor |
Other [Manufacturer of natural plant based Food ingredients and Nutraceutical ingredients] |
|
|
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 Siju C Thomas |
Akay Natural Ingredients Pvt. Ltd |
Department of Research and Development,Room No:2, 1st Floor, R&D Building, Malaidamthuruthu P. O.
Ernakulam
KERALA |
944742049
drsijuthomas@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Balaji Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
With Normal Hematological and Biochemical Parameters |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CC-AK-23 |
200 mg,Capsule,Single day, single-dose oral administration of CC-AK-23 |
| Comparator Agent |
CC-AK-23 |
200 mg,Sachet,Single day, single-dose oral administration of CC-AK-23 |
| Intervention |
FC-AK-23 |
200 mg,Capsule,Single day, single-dose oral administration of FC-AK-23 |
| Intervention |
FC-AK-23 |
200 mg,Sachet,Single day, single-dose oral administration of FC-AK-23 |
| Comparator Agent |
UFC-AK-23 |
200 mg,Capsule,Single day, single-dose oral administration of UFC-AK-23 |
| Comparator Agent |
UFC-AK-23 |
200 mg,Sachet,Single day, single-dose oral administration of UFC-AK-23 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1.Healthy non-smoking volunteers who are not involved in any regular medication or supplementation.
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 who understands the study procedures, is ready to comply and provide signed informed consent form (ICF) to participate in the study.
4.Subjects having body mass index (BMI) in between 19-26 kg/m2.
|
|
| ExclusionCriteria |
| Details |
1.Subjects who have consumed caffeine supplements within 2 days prior to the screening
2.Subjects having symptoms of viral infection.
3.Pregnant or lactating women.
4.Subjects with known hypersensitivity to the investigational products (IP).
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 subject’s participation in the trial.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To estimate the concentrations of formulated caffeine (FC-AK-23) in comparison with normal unformulated caffeine (UFC-AK-23) and a commercial caffeine supplementation (CC-AK-23). |
Baseline,Day 1, Day 7, Day 13, Day 19, Day 25, Day 31 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pharmacokinetic parameters of formulated caffeine (FC-AK-23) in comparison with unformulated (UFC-AK-23) and commercial caffeine supplementation (CC-AK-23). |
Baseline,Day 1, Day 7, Day 13, Day 19, Day 25, Day 31 |
| The safety & tolerability of FC-AK-23, UFC-AK-23 and CC-AK-23. |
Baseline,Day 1, Day 7, Day 13, Day 19, Day 25, Day 31 |
|
|
Target Sample Size
|
Total Sample Size="14"
Sample Size from India="14"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
10/04/2024 |
| 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="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a comparative single-dose, 2-way crossover,
6-sequence study to compare the bioavailability of formulated caffeine
(FC-AK-23) in comparison with normal unformulated caffeine (UFC-AK-23) and a
commercial caffeine supplementation (CC-AK-23).
A group of 14 healthy volunteers willing to give written informed consent will be screened on Visit 1 to confirm their eligibility. Subjects fulfilling the eligibility criteria will be assigned to 1 of 6 treatments on Visit 2 followed by treatment sequences 2, 3,
4, 5, and 6 on subsequent visits (Visit 3, 4, 5, 6 & 7). There will be 5 washout periods in between the 5 doing days.
|