| CTRI Number |
CTRI/2019/11/022135 [Registered on: 25/11/2019] Trial Registered Prospectively |
| Last Modified On: |
09/12/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
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Type of Study
|
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| Study Design |
Other |
|
Public Title of Study
|
To check the difference of two products that is product A (Xtenergy caffeine 60%, 200 mg caffeine/ Capsule) and product B (Natural caffeine extract 99%,200 mg caffeine/Capsule) in the healthy adult human beings. |
|
Scientific Title of Study
|
A double blind, balanced, randomized, single-dose, two-treatment, two-sequence, two-period, crossover oral bioequivalence study of Product A (Xtenergy caffeine60%, 200 mg caffeine/ Capsule)of OmniActive Health Technologies Ltd., Indiaand Product B(Natural caffeine extract 99%,200 mg caffeine/Capsule)of OmniActive Health Technologies Ltd., Indiain healthy adult human subjects under fasting condition. |
| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr T Harish Ramnarayan |
| Designation |
Principal Investigator |
| Affiliation |
ClinSync Clinical Research Pvt Ltd |
| Address |
JSR Mall Plot No.7 to 18
Madinaguda Village Serilingampally Mandal
Hyderabad-500050 Telangana India.
Hyderabad
TELANGANA
500050
India |
| Phone |
|
| Fax |
|
| Email |
harishramnarayan.t@clinsynccro.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr T Harish Ramnarayan |
| Designation |
Principal Investigator |
| Affiliation |
ClinSync Clinical Research Pvt Ltd |
| Address |
JSR Mall Plot No.7 to 18
Madinaguda Village Serilingampally Mandal
Hyderabad-500050 Telangana India.
Hyderabad
TELANGANA
500050
India |
| Phone |
|
| Fax |
|
| Email |
harishramnarayan.t@clinsynccro.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr T Harish Ramnarayan |
| Designation |
Principal Investigator |
| Affiliation |
ClinSync Clinical Research Pvt Ltd |
| Address |
JSR Mall Plot No.7 to 18
Madinaguda Village Serilingampally Mandal
Hyderabad-500050 Telangana India.
Hyderabad
TELANGANA
500050
India |
| Phone |
|
| Fax |
|
| Email |
harishramnarayan.t@clinsynccro.com |
|
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Source of Monetary or Material Support
|
| OmniActive Health Technologies Ltd
A-10, Road No. 1, Wagle Industrial Estate, Thane (W) - 400604 |
|
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Primary Sponsor
|
| Name |
OmniActive Health Technologies Ltd |
| Address |
A-10, Road No. 1, Wagle Industrial Estate,
Thane (W) -400604, India.
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
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Details of Secondary Sponsor
|
| Name |
Address |
| ClinSync Clinical Research PVt Ltd |
JSR Mall, Plot No.7 to 18,
Madinaguda Village, Serilingampally Mandal,
Hyderabad-500050, Telangana, India.
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrT Harish Ramnarayan |
ClinSync Clinical Research Pvt. Ltd. |
JSR Mall, Plot No.7 to 18,
Madinaguda Village, Serilingampally Mandal,
Hyderabad-500050, Telangana, India.
Hyderabad
TELANGANA |
9966686544
harishramnarayan.t@clinsynccro.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maarg Independent Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Indian healthy adult human subjects under fasting condition |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Natural caffeine extract |
Natural caffeine extract 99%, 200 mg caffeine/Capsule manufactured byOmniActive Health Technologies Ltd., India.
Dose: 200 mg caffeine for 1 day
One capsule as a single dose to each subject
Orally with 240 ± 2 mL of water
Single dose in the study as per randomization
scheme. |
| Intervention |
Xtenergy caffeine 60%, 200 mg caffeine/ Capsule |
Xtenergy caffeine 60%, 200 mg caffeine/ Capsule. OmniActive Health Technologies Ltd
Dose: 200 mg caffeine for 1 day
Orally with 240 ± 2 mL of water
Single dose in the study as per randomization
scheme
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy, adult, human subjects within the age range of ≥ 18 ≤ 55 years
2. BMI between 18.5 – 24.9Kg/m2.
3. Coffee drinkers with 1-2 cups of coffee per day (no more than 16 cups of coffee per week).
4. Subject is a non-smoker and non-alcoholic. |
|
| ExclusionCriteria |
| Details |
Institutionalized subjects.
Subjects having contraindications or hypersensitivity to study IP or related group of IP.
Systolic blood pressure less than 90 mm Hg or more than 130 mm Hg.
Diastolic blood pressure less than 60 mm Hg or more than 80 mm Hg.
Pulse rate less than 60 beats/minute or more than 100 beats/minute.
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Method of Generating Random Sequence
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Method of Concealment
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Blinding/Masking
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Primary Outcome
|
| Outcome |
TimePoints |
| To compare the rate and extent of absorption of Product A (Xtenergy caffeine 60%, 200 mg caffeine/ Capsule)of OmniActive Health Technologies Ltd., India and Product B(Natural caffeine extract 99%, 200 mg caffeine/Capsule)of OmniActive Health Technologies Ltd., Indiain healthy human adult subjects under fastingcondition. |
In each period the pre-dose samples at -4.00, 0.00 hr (1 x 04 mL) and post-dose blood samples (1 x 04 mL) at0.25, 0.50, 0.75, 1.00, 2.00, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 9.00, 10.00, 12.00, and 24.00hours will be collected. |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| 1. To evaluate changes in Caffeine Research Visual Analogue Scales (Caff-VAS) consisting of seven visual analogue scales ("relaxed", "alert", "jittery", "tired", "tense", "headache", “overall mood") from baseline (0.00 hr) to1hr, 2hr, 4hr, 6hr, 8hr, 10hr,and 12hr. |
In each period the pre-dose samples at -4.00, 0.00 hr (1 x 04 mL) and post-dose blood samples (1 x 04 mL) at0.25, 0.50, 0.75, 1.00, 2.00, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 9.00, 10.00, 12.00, and 24.00hours will be collected. |
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Target Sample Size
|
Total Sample Size="26"
Sample Size from India="26"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="26" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/11/2019 |
| Date of Study Completion (India) |
08/12/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="11" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
To compare
the rate and extent of absorption of Product A (Xtenergy
caffeine 60%, 200 mg caffeine/ Capsule)of OmniActive Health Technologies Ltd., India
and Product B(Natural caffeine extract 99%, 200 mg caffeine/Capsule)of OmniActive Health Technologies Ltd., Indiain healthy human
adult subjects under fastingcondition. |