Description
Requirements of compliance: -The Investigator (or designated study physician) must be informed as soon as possible about any medication taken from the time of screening until the end of the clinical phase of the study (follow-up visit). -Subjects must refrain from strenuous exercise for 48 hours before the screening visit, each treatment period and follow-up visit. -Subjects must refrain from alcohol for 24 hours prior to each treatment period until discharge from the unit (on each respective treatment period). -Subjects must refrain from grapefruit or grapefruit juice containing products from 7 days pre-dose until discharge from the unit on each dosing occasion. -Subjects must refrain from foods or beverages containing caffeine from 24 hours prior to treatment periods until discharge from the unit (on each respective treatment period). -Subjects must refrain from all recreational drugs throughout the study (screening to follow-up). Drugs of abuse tests will be performed randomly throughout the study to check this. A confirmed positive result will lead to withdrawal from the study. A minimum list of drugs that will be screened for include Amphetamines, Barbituates, Cocaine, Opiates, Cannabinoids and Benzodiazepines.
Data type
text
Alias
- UMLS CUI [1,1]
- C0525058
- UMLS CUI [1,2]
- C2065135