Tolerability of Asasantin in Healthy Female and Male Subjects

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

Official Title
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Tolerability of a Two Week Treatment With Asasantin Extended Release 200/25 mg Capsules b.i.d., Compared to Reduced Dose During the First Week of Treatment in a Double-blind, Randomised, Placebo Controlled Parallel Group Comparison Trial in Healthy Female and Male Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: Asasantin ER
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Asasantin ER<br>Administered once daily (days 1 to 7), followed by twice daily administration (days 8 to 14) | Drug: Asasantin ER<br> <br> |
| Experimental: Asasantin ER, administered twice daily from day 1 to day 14<br> | Drug: Asasantin ER<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects experiencing moderate/severe headache |  | Day 14 after first drug administration | 
| 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 | 
| Changes from baseline in laboratory tests |  | Pre-dose and day 17 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 |