Status:
COMPLETED
Tolerability of Asasantin in Healthy Female and Male Subjects
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
To investigate the occurrence of dipyridamole associated headaches in healthy subjects using a titration scheme or not
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT02269228
Start Date
February 1 2000
Last Update
October 21 2014
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.