| CTRI Number |
CTRI/2021/06/034185 [Registered on: 11/06/2021] Trial Registered Prospectively |
| Last Modified On: |
16/09/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A clinical trial study to determine the oral bio-availability of Caffxtend capsules. |
|
Scientific Title of Study
|
An open-label, balanced, randomized, single dose, two treatment, two sequence, two period, two way crossover oral bio-availability study comparing caffxtend capsules 200 mg (caffeine long acting beadlets 50N 400mg, equivalent to natural caffeine 200 mg, filled in to capsules) manufactured by Inventia healthcare limited with caffeine capsules 200 mg manufactured by Unicorn natural products ltd in healthy adult human subjects under fasting conditions. |
| Trial Acronym |
CAFF |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr R Senthurselvi |
| Designation |
Principal Investigator |
| Affiliation |
MBBS MD |
| Address |
Clinical Trial Division
Spinos Lifescience and Research Pvt Ltd
29 A Krishna Maduravanam
Vellakinaru Pirivu G N Mills post
Coimbatore
TAMIL NADU
641029
India |
| Phone |
|
| Fax |
|
| Email |
senthurselvi.r@spinoslifescience.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R Senthurselvi |
| Designation |
Principal Investigator |
| Affiliation |
MBBS MD |
| Address |
Clinical Trial Division
Spinos Lifescience and Research Pvt Ltd
29 A Krishna Maduravanam
Vellakinaru Pirivu G N Mills post
Coimbatore
TAMIL NADU
641029
India |
| Phone |
|
| Fax |
|
| Email |
senthurselvi.r@spinoslifescience.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr R Senthurselvi |
| Designation |
Principal Investigator |
| Affiliation |
MBBS MD |
| Address |
Clinical Trial Division
Spinos Lifescience and Research Pvt Ltd
29 A Krishna Maduravanam
Vellakinaru Pirivu G N Mills post
Coimbatore
TAMIL NADU
641029
India |
| Phone |
|
| Fax |
|
| Email |
senthurselvi.r@spinoslifescience.com |
|
|
Source of Monetary or Material Support
|
| Inventia Healthcare Limited
Unit 703-704, 7th floor, Hubtown Solaris, N.S. Phadkemarg, Andheri (East) Mumbai-400069 |
|
|
Primary Sponsor
|
| Name |
Inventia Healthcare Limited |
| Address |
Unit 703-704, 7th floor, Hubtown Solaris, N.S. Phadkemarg, Andheri (East) Mumbai-400069 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 R Senthurselvi |
Spinos Lifescience and Research Pvt Ltd |
Clinical Trial Division
29 A Krishna Maduravanam Vellakinar Pirivu G N Mills Post
Coimbatore
TAMIL NADU |
9750722032
senthurselvi.r@spinoslifescience.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy adult human subjects under fasting condition |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Caffeine capsules |
200 mg
Oral dose
20 days |
| Intervention |
Caffxtend capsules |
200 mg
Oral dose
20 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Body Mass Index between 18.50 to 29.99 kg/m2
Subjects who have no evidence of underlying diseases during screening
Subjects whose screening laboratory values are within normal limits
Healthy as documented by medical history, physical examination, vital sign assessments, 12 lead ECG, X-ray and realted clinical laboratory assessments.
Female subjects within normal limits or clinically non-significant laboratory
evaluation results for FSH & LH. |
|
| ExclusionCriteria |
| Details |
Evidence of allergy or known hypersensitivity to caffeine or any of the ingredients of
the products.
Any major illness in the last three months or any significant ongoing chronic medical
illness.
Renal or liver impairment.
History or presence of alcohol addiction or abuse.
Subjects who had participated in any other study within the 90 days of check-in. |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the oral bioavailability of different caffeine capsules |
00.25, 00.50, 00.75, 01.00, 01.50, 02.00, 03.00, 04.00, 05.00, 06.00, 08.00, 10.00,
12.00, 24.00, 36.00 and 48.00 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To monitor the safety and tolerability of a single dose administered in healthy human adult subjects under fasting conditions |
00.25, 00.50, 00.75, 01.00, 01.50, 02.00, 03.00, 04.00, 05.00, 06.00, 08.00, 10.00,
12.00, 24.00, 36.00 and 48.00 hours |
|
|
Target Sample Size
|
Total Sample Size="16"
Sample Size from India="16"
Final Enrollment numbers achieved (Total)= "16"
Final Enrollment numbers achieved (India)="16" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
05/07/2021 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Caffeine belongs to the methyl xanthine class used for a variety of purposes, including certain respiratory conditions of the premature newborn, pain relief, and to combat drowsiness. Caffeine is similar in chemical structure to Theophylline andTheobromine.
A clinical trial study to determine the oral bioavailability of caffeine capsules. In each period subjects will be housed in the clinical facility for at least 11.00 hours pre-dose to 48.00 hours post-dose and the washout period of at least 04 days from the successive dosing day.
Pharmacokinetic & Statistical Parameters: Employing the estimated concentration vs. time profiles of Caffeine using SAS® software Version 9.4 or higher version of SAS Institute Inc., USA or applicable software, the following pharmacokinetic parameters will be calculated: Primary parameters are Cmax, AUC0-t & AUC0-. Secondary parameters are tmax, Kel, t½and AUC_%Extrap_obs. Statistical analysis for Caffeine will be done using SAS® software Version 9.4 or higher version of SAS Institute Inc., USA. Caff-VAS Questionnaires at different time points will be analyzed. The mean and change from baseline will be analyzed and treatments will be compared using appropriate statistical method.
|