To investigate the occurrence of dipyridamole associated headaches in healthy subjects using a titration scheme or not
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
Cumulated headache (intensity x duration) per day based on mean severity per waking hours expressed as area under the curve (AUC)
Time frame: Day 14 after first drug administration
Proportion of subjects experiencing moderate/severe headache
Time frame: Day 14 after first drug administration
Proportion of subjects experiencing headache
Time frame: Day 14 after first drug administration
Cumulated headache (intensity x duration) per day based on maximum severity per day expressed as AUC
Time frame: Day 14 after first drug administration
Amount of acetylsalicylic acid (ASA) 500 used to cut headache
Time frame: Day 14 after first drug administration
Changes from baseline in vital signs
Time frame: Pre-dose and day 17 after first drug administration
Changes from baseline in laboratory tests
Time frame: Pre-dose and day 17 after first drug administration
Changes from baseline in 12-lead ECG
Time frame: Pre-dose and day 17 after first drug administration
Changes from baseline in physical examination
Time frame: Pre-dose and day 17 after first drug administration
Number of patients with adverse events
Time frame: Up to day 17 after first drug administration
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