Pilot study designed to characterize the plasma caffeine pharmacokinetic profile of encapsulated caffeine when consumed in the fasted and fed states.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
18
Zero calorie 500 ml (16.9 oz) flavored, carbonated energy beverage
GCP Research
St. Petersburg, Florida, United States
Area under the concentration curve for plasma caffeine (AUC0-t)
Plasma caffeine pharmacokinetics
Time frame: Changes from pre-dose to 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, and 6 hours after the first sip of beverage ingestion
Peak caffeine concentration (Cmax)
Plasma caffeine pharmacokinetics
Time frame: Changes from pre-dose to 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, and 6 hours after the first sip of beverage ingestion
Time to maximal plasma caffeine concentration (Tmax)
Plasma caffeine pharmacokinetics
Time frame: Changes from pre-dose to 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, and 6 hours after the first sip of beverage ingestion
Plasma caffeine concentration by time profile
Plasma caffeine pharmacokinetics
Time frame: Changes from pre-dose to 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, and 6 hours after the first sip of beverage ingestion
Vital sign measurement: Systolic and diastolic blood pressure
Safety parameter: Blood pressure
Time frame: Changes in systolic and diastolic blood pressure over 6.5 hours, from prior to blood sample collection at -30 minutes pre-dose to 2 and 6 hours after the first sip of beverage ingestion
Vital sign measurement: Heart rate
Safety parameter: Heart rate
Time frame: Changes in heart rate over 6.5 hours, from prior to blood sample collection at -30 minutes pre-dose to 2 and 6 hours after the first sip of beverage ingestion
Occurrence of Adverse events
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Safety parameter: Treatment-emergent AEs (TEAEs) and adverse drug reactions (ADRs)
Time frame: From the first sip of beverage ingestion (Time 0) of the first dosing day, until the subject exits the study the evening of the second and last dosing day. The two dosing days are approximately 7 days apart.