1.Has the subject fasted from all food and drink (except water) for at least 4 hours prior to any clinical safety labs?
Item
1.Has the subject fasted from all food and drink (except water) for at least 4 hours prior to any clinical safety labs?
boolean
C0015663 (UMLS CUI [1])
2. Has the subject maintained their normal smoking habit?
Item
2. Has the subject maintained their normal smoking habit?
boolean
C1519386 (UMLS CUI [1])
3. Has the subject refrained from consuming xanthine-containing foods and beverages?
Item
3. Has the subject refrained from consuming xanthine-containing foods and beverages?
boolean
C0043314 (UMLS CUI [1,1])
C0016452 (UMLS CUI [1,2])
C0443288 (UMLS CUI [1,3])
4. Has the subject refrained from consuming food containing CYP1A2 inducing constituents?
Item
4. Has the subject refrained from consuming food containing CYP1A2 inducing constituents?
boolean
C1827490 (UMLS CUI [1,1])
C0443288 (UMLS CUI [1,2])
C0016452 (UMLS CUI [1,3])
5. Has the subject refrained from taking quinine?
Item
5. Has the subject refrained from taking quinine?
boolean
C0034417 (UMLS CUI [1,1])
C0443288 (UMLS CUI [1,2])
6. Has the subject refrained from alcohol?
Item
6. Has the subject refrained from alcohol?
boolean
C0001948 (UMLS CUI [1,1])
C0443288 (UMLS CUI [1,2])
7.Prescription of drug (procedure) | OTC - Over The Counter; Pharmaceutical Preparations | Vitamins | Minerals | Medicinal Herbs | Interferes with; Procedure (set of actions) | compromise; patient safety
Item
7. Has the subject been prescribed medication for the first time within 14 days or over-the- counter (OTC) medicine within 7 days (except HRT and OCPs), or vitamins, minerals and herbal remedies within 48 hours before the first dosing day, which in the opinion of the Principal Investigator may interfere with the study procedures or compromise a subject’s safety? A subject must have been taking their prescribed HRT or OCP for at least 2 days before the first dose of study medication.
text
C2239117 (UMLS CUI [1])
C2709201 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0042890 (UMLS CUI [3])
C0026162 (UMLS CUI [4])
C0025125 (UMLS CUI [5])
C0521102 (UMLS CUI [6,1])
C2700391 (UMLS CUI [6,2])
C2945640 (UMLS CUI [7,1])
C1113679 (UMLS CUI [7,2])
8. Has the subject refrained from taking antacids?
Item
8. Has the subject refrained from taking antacids?
boolean
C0003138 (UMLS CUI [1,1])
C0443288 (UMLS CUI [1,2])
Item
Meals and Fluid Intake - Timepoint
integer
C1998602 (UMLS CUI [1,1])
C0429791 (UMLS CUI [1,2])
C2348792 (UMLS CUI [1,3])
Code List
Meals and Fluid Intake - Timepoint
CL Item
Breakfast 8 AM (1)
CL Item
Lunch 11:30 AM - 12 PM (2)
CL Item
Evening Meal 7 - 7:30 PM (3)
CL Item
Snack ~11 PM (Prior to Bedtime) (4)
Meals and Fluid Intake - Date
Item
Meals and Fluid Intake - Date
date
C1998602 (UMLS CUI [1,1])
C0429791 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Actual time meal completed
Item
Actual time meal completed
time
C1998602 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Did subject complete meal?
Item
Did subject complete meal?
boolean
C1998602 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Meals and Fluid Intake - Comments
Item
Meals and Fluid Intake - Comments
text
C1998602 (UMLS CUI [1,1])
C0429791 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
Did subject have a drink?
Item
Did subject have a drink?
boolean
C0452428 (UMLS CUI [1])
Item
Meals and Fluid Intake - Timepoint
integer
C1998602 (UMLS CUI [1,1])
C0429791 (UMLS CUI [1,2])
C2348792 (UMLS CUI [1,3])
Code List
Meals and Fluid Intake - Timepoint
CL Item
Breakfast 8 AM (1)
CL Item
Lunch 11:30 AM - 12 PM (2)
CL Item
Afternoon Meal 5 PM (3)
Meals and Fluid Intake - Date
Item
Meals and Fluid Intake - Date
date
C1998602 (UMLS CUI [1,1])
C0429791 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Actual time meal completed
Item
Actual time meal completed
time
C1998602 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Did subject complete meal?
Item
Did subject complete meal?
boolean
C1998602 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Meals and Fluid Intake - Comments
Item
Meals and Fluid Intake - Comments
text
C1998602 (UMLS CUI [1,1])
C0429791 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
Did subject have a drink?
Item
Did subject have a drink?
boolean
C0452428 (UMLS CUI [1])