N/A N/A
Conditions
Interventions
Caffeinated beverage containing approximately 135 mg caffeine or capsule
containing 200 mg caffeine.
Sponsors
Centre for Human Drug Research
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Subject must be 18-35 years of age (inclusive) - Subject has a Body Mass Index (BMI) between 18 and 30 kg/m2 (inclusive) and body weight between 50 kg and 90 kg (inclusive); - Subject is able to read and understand the written consent form, complete study-related procedures, and communicate with the study staff; - Subject is willing to comply with study restrictions.
Exclusion criteria
Exclusion criteria: - Clinically relevant abnormal history of physical and mental health as determined by medical history taking and physical examinations obtained during the screening visit (as judged by the investigator); - Clinically relevant abnormal laboratory results, ECG, vital signs, or physical findings at screening (as judged by the investigator); - Positive test for hepatitis B, C or HIV at screening; - Positive urinary pregnancy test (females only) at screening; - History of alcoholism or substance abuse within three years prior to screening; - Male subjects habitually using more than 21 units of alcohol per week and female subjects using more than 14 units of alcohol per week; - Positive urine drug screen at screening; - Subject uses more than 5 units of xanthine-containing food products or drinks (including but not limited to coffee, tea, Red Bull, chocolate) daily; - Subject is a smoker (> 5 cigarettes per day) or has used nicotine/nicotine-containing products within 3 months prior to screening; - Subject is unable to refrain from the use of disallowed concomitant medication, dietary supplements or food products from one week prior to the first caffeine administration until the end of the last occasion; - Subject is unable to refrain from food and drinks containing a xanthine (e.g. chocolate, cola, energy drinks, coffee or tea) from from 3 days prior to until the end of the study days; - Participation in an investigational drug study within 90 days prior to the first dose and/or participation in more than 4 clinical trials in the last year; - Donation or loss of blood (> 500 mL) within 3 months prior to screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Descriptive statistics of PK in blood and saliva and PK modelling. | — |
Countries
Netherlands
Outcome results
None listed