None listed
Conditions
Interventions
Intervention1: ND 10 tablet Caffeine: 400 mg tablets
Oral dose
3 times (3 tablets at every 8 hours)
Control Intervention1: ND 10 SR Tablets: 400 mg tablets
Oral dose
2 times (2 tablets at every 12 hou
Sponsors
Mr Anand Bhogu
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the rate and extent of absorption of caffeine Immediate Release Tablets 400 mg at a dose 3 X 400 mg comparing with caffeine Modified Release Tablets 400 mg at a dose 2 X 400 mgTimepoint: 34 times points 00.00 hours 00.50, 01.00, 01.50, 02.00, 02.50, 03.00, 03.50, 04.00, 05.00, 06.00, 08.00, 08.50, 09.00, 09.50, 10.00, 10.50, 11.00, 11.50, 12.00, 13.00, 14.00, 16.00, 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
| Measure | Time frame |
|---|---|
| To compare the safety and tolerability of caffeine Immediate Release Tablets 400 mg at a dose 3 X 400 mg comparing with caffeine Modified Release Tablets 400 mg at a dose 2 X 400 mgTimepoint: 34 times points 00.00 hours 00.50, 01.00, 01.50, 02.00, 02.50, 03.00, 03.50, 04.00, 05.00, 06.00, 08.00, 08.50, 09.00, 09.50, 10.00, 10.50, 11.00, 11.50, 12.00, 13.00, 14.00, 16.00, 16.50, 17.00, 17.50, 18.00, 18.50, 19.00, 19.50, 20.00, 21.00, 22.00 and 24.00 hours | — |
Countries
India
Contacts
Public ContactDr Agrawal Neeta Subashchandra M B B S
Jeevan Scientific Technology Ltd
Outcome results
None listed