A study to determine safety of Caffeine tablets
- Registration Number
- CTRI/2023/02/049999
- Lead Sponsor
- Mr Anand Bhogu
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
Healthy, adult, human subjects between 18-45 years of age (including both) and weight less than or equal to 50 Kg
Acceptable findings during registration and screening including medical history
physical examination laboratory evaluations 12 lead ECG and Chest X-Ray
Values within normal ranges of laboratory parameters upon evaluation by the
Investigator or Physician.
Subjects able to communicate effectively with study personnel.
Subjects willing to give written informed consent and adhere to all the requirements of this protocol.
Subject willing to abstain from all kinds of caffeine/xanthine containing foods or
grapefruit or grapefruit juice from 72.00 hours prior to admission until last blood
sample collection in each study period
Subjects having a history of contraindication or hypersensitivity to caffeine or related products
history or presence of significant asthma urticaria or other allergic-type
reactions after taking aspirin or other NSAIDs
History or presence of gastrointestinal (GI) inflammation bleeding ulceration
and perforation of the stomach small intestine or large intestine
History or evidence of exfoliative dermatitis, Stevens - Johnson syndrome (SJS),
and toxic epidermal necrolysis
Have significant diseases or clinically significant abnormal findings during
screening
Any known enzyme inducing or inhibiting drug taken within 14 days before the
study
Participation in a drug research study within 90 days prior to admission of this
study
Blood loss or whole blood donation within 90 days prior to drug administration
Consumption of high caffeine (more than 5 cups of coffee or tea/day)
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the rate and extent of absorption of caffeine Immediate <br/ ><br>Release Tablets 400 mg at a dose 3 X 400 mg comparing with caffeine <br/ ><br>Modified Release Tablets 400 mg at a dose 2 X 400 mgTimepoint: 34 times points <br/ ><br>00.00 hours <br/ ><br>00.50, 01.00, 01.50, 02.00, 02.50, 03.00, 03.50, 04.00, 05.00, 06.00, <br/ ><br>08.00, 08.50, 09.00, 09.50, 10.00, 10.50, 11.00, 11.50, 12.00, 13.00, 14.00, 16.00, <br/ ><br>16.50, 17.00, 17.50, 18.00, 18.50, 19.00, 19.50, 20.00, 21.00, 22.00 and 24.00 hours
- Secondary Outcome Measures
Name Time Method To compare the safety and tolerability of caffeine Immediate <br/ ><br>Release Tablets 400 mg at a dose 3 X 400 mg comparing with caffeine <br/ ><br>Modified Release Tablets 400 mg at a dose 2 X 400 mgTimepoint: 34 times points <br/ ><br>00.00 hours <br/ ><br>00.50, 01.00, 01.50, 02.00, 02.50, 03.00, 03.50, 04.00, 05.00, 06.00, <br/ ><br>08.00, 08.50, 09.00, 09.50, 10.00, 10.50, 11.00, 11.50, 12.00, 13.00, 14.00, 16.00, <br/ ><br>16.50, 17.00, 17.50, 18.00, 18.50, 19.00, 19.50, 20.00, 21.00, 22.00 and 24.00 hours