Healthy
Conditions
Brief summary
To investigate the relative bioavailability of the proposed formulation of PERSANTIN® compared to the present commercial formulation.
Interventions
DRUGPersantin® new formulation
DRUGPersantin® commercial formulation
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
21 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* All participants in the study should be healthy males, range from 21 to 50 years of age and their body mass index (BMI) be within 18.5 to 29.9 kg/m2 * All participants must give their written informed consent in accordance with Good Clinical Practice and local legislation prior to admission to the study
Exclusion criteria
* Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance * Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders * Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders * History of orthostatic hypotension, fainting spells or blackouts * Chronic or relevant acute infections * History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator * Intake of drugs with a long half-life (\> 24 hours) within at least one month or less than 10 half-lives of the respective drug before enrolment in the study or during the study * Use of any drugs which might influence the results of the trial up to 7 days prior to enrolment in the study or during the study * Participation in another trial with an investigational drug (\<= two months prior to administration or during the trial) * Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day) * Inability to refrain from smoking on trial days * Alcohol abuse (\> 60 g/day) * Drug abuse * Blood donation (\>= 100 ml within four weeks prior to administration or during the trial) * Any laboratory value outside the clinically accepted reference range * Excessive physical activities within the last week before the trial or during the trial Following
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the concentration time curve from 48 to 58 hours (AUC48-58) | 48 - 58 hours |
| Maximum concentration from 48 to 58 hours (Cmax48-58) | 48 - 58 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cmax48-58/AUC48-58 ratio | 48 - 58 hours | — |
| Time to maximum concentration from 48 to 58 hours (Tmax48-58) | up to 58 hours | — |
| Amount excreted in urine (Ae) | up to 24 hours after drug administration | — |
| Peak trough fluctuation (% PTF) | up to 48 hours | — |
| Number of participants with clinically significant findings in vital functions | up to 8 days after last drug administration | blood pressure, pulse rate |
| Number of participants with clinically significant findings in ECG | up to 8 days after last drug administration | — |
| Number of participants with clinically significant findings in laboratory tests | up to 8 days after last drug administration | — |
| Number of participants with adverse events | up to 8 days after last drug administration | — |
| Minimum concentration from 48 to 58 hours (Cmin48-58) | 48 - 58 hours | — |
Outcome results
None listed