Healthy
Conditions
Brief summary
To investigate the occurrence of dipyridamole associated headaches in healthy subjects using a titration scheme or not
Interventions
DRUGAsasantin ER
DRUGPlacebo
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* All participants in the study should be healthy females/males, range from 18 to 55 years of age and be within a Broca Index of ≥ - 20 % and ≤ + 20 % * Prior to admission to the study all subjects will have given, in accordance with good clinical practice (GCP) and the local legislation, their written informed consent.
Exclusion criteria
* Subjects will be excluded from the study if the results of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and are of clinical relevance * Subjects with known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders * Subjects with diseases of the central nervous system (such as epilepsy) or with psychiatric disorders or neurological disorders * Subjects with known history of orthostatic hypotension, fainting spells or blackouts * Subjects with chronic or relevant acute infections * Subjects with history of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator * Subjects who have taken a drug with a long half-life (\> 24 hours) (≤ 1 month prior to administration or during the trial) * Subjects who received any other drugs which might influence the results of the trial (≤ 10 days prior to administration or during the trial) * Subjects who have participated in another study with an investigational drug (≤ 1 month prior to administration or during the trial) * Subjects who smoke more than 15 cigarettes or 4 cigars or 4 pipes/day * Subjects who are not able to refrain from excessive consumption of methylxanthine containing drinks or food * Subjects who drink more than 60 g of alcohol per day * Subjects who are dependent on drugs * Subjects who have donated blood (\> 400 ml) (≤ 4 weeks prior to administration or during the trial) * Subjects who have participated in excessive physical activities (≤ 5 days prior to administration or during the trial) For female subjects: * Pregnancy * Positive pregnancy test * No adequate contraception (acceptable: e.g. sterilisation, intrauterine devices (IUD), oral contraceptives, condoms) * Inability to maintain this adequate contraception during the whole study period * Lactation period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cumulated headache (intensity x duration) per day based on mean severity per waking hours expressed as area under the curve (AUC) | Day 14 after first drug administration |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects experiencing headache | Day 14 after first drug administration |
| Cumulated headache (intensity x duration) per day based on maximum severity per day expressed as AUC | Day 14 after first drug administration |
| Amount of acetylsalicylic acid (ASA) 500 used to cut headache | Day 14 after first drug administration |
| Changes from baseline in vital signs | Pre-dose and day 17 after first drug administration |
| Proportion of subjects experiencing moderate/severe headache | Day 14 after first drug administration |
| Changes from baseline in 12-lead ECG | Pre-dose and day 17 after first drug administration |
| Changes from baseline in physical examination | Pre-dose and day 17 after first drug administration |
| Number of patients with adverse events | Up to day 17 after first drug administration |
| Changes from baseline in laboratory tests | Pre-dose and day 17 after first drug administration |
Outcome results
None listed