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
Asasantin ER
+ Placebo
Treatment Study
Summary
Study start date: February 1, 2000
Actual date on which the first participant was enrolled.To investigate the occurrence of dipyridamole associated headaches in healthy subjects using a titration scheme or not
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.100 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 55 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.3 intervention groups are designated in this study
33.333% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalGroup III
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives