Tolerability of Asasantin in Healthy Female and Male Subjects

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

To investigate the occurrence of dipyridamole associated headaches in healthy subjects using a titration scheme or not

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Aspirin, Dipyridamole Drug Combination

Criteria

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