Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Pilot study designed to characterize the plasma caffeine pharmacokinetic profile of encapsulated caffeine when consumed in the fasted and fed states.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fed state | Experimental | Standardized high fat breakfast before dosing |
|
| Fasted state | Experimental | Remain fasted for 4 hours post-dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 250 mg encapsulated caffeine | Other | Zero calorie 500 ml (16.9 oz) flavored, carbonated energy beverage |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration curve for plasma caffeine (AUC0-t) | Plasma caffeine pharmacokinetics | 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 | 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 | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Vital sign measurement: Systolic and diastolic blood pressure | Safety parameter: Blood pressure | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lawrence Galitz, MD | GCP, Global Clinical Professionals | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GCP Research | St. Petersburg | Florida | 33705 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Safety parameter: Heart rate |
| 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 | Safety parameter: Treatment-emergent AEs (TEAEs) and adverse drug reactions (ADRs) | 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. |