Pharmacokinetics of Two Different Persantin® Sugar Coated Tablets in Healthy Male Volunteers
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT02259998
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
To investigate the relative bioavailability of the proposed formulation of PERSANTIN® compared to the present commercial formulation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 30
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
Read More
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 exclusion criteria are of special interest for this study:
- History of haemorrhagic diathesis
- History of gastro-intestinal ulcer, perforation or bleeding
- Glucose-6-phosphate-dehydrogenase (G-6-PD) deficiency
Read More
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Persantin® commercial formulation Persantin® commercial formulation - Persantin® new formulation Persantin® new formulation -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Peak trough fluctuation (% PTF) up to 48 hours Minimum concentration from 48 to 58 hours (Cmin48-58) 48 - 58 hours 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 Number of participants with adverse events up to 8 days after last drug administration 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