NCT Number: NCT02259998
Pharmacokinetics of Two Different Persantin® Sugar Coated Tablets in Healthy Male Volunteers
To investigate the relative bioavailability of the proposed formulation of PERSANTIN® compared to the present commercial formulation.
Looking for future studies?
Notify MeKey information
Conditions
Age range
21 year–50 year
Sex eligibility
Male
Study type
Interventional
Phase
Phase 1
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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 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
Treatment and study plan
Persantin® commercial formulation
DrugPrimary outcomes
-
Area under the concentration time curve from 48 to 58 hours (AUC48-58)
Time frame: 48 - 58 hours
-
Maximum concentration from 48 to 58 hours (Cmax48-58)
Time frame: 48 - 58 hours
Secondary outcomes
-
Peak trough fluctuation (% PTF)
Time frame: up to 48 hours
-
Minimum concentration from 48 to 58 hours (Cmin48-58)
Time frame: 48 - 58 hours
-
Cmax48-58/AUC48-58 ratio
Time frame: 48 - 58 hours
-
Time to maximum concentration from 48 to 58 hours (Tmax48-58)
Time frame: up to 58 hours
-
Amount excreted in urine (Ae)
Time frame: up to 24 hours after drug administration
-
Number of participants with adverse events
Time frame: up to 8 days after last drug administration
-
Number of participants with clinically significant findings in vital functions
Time frame: up to 8 days after last drug administration
blood pressure, pulse rate
-
Number of participants with clinically significant findings in ECG
Time frame: up to 8 days after last drug administration
-
Number of participants with clinically significant findings in laboratory tests
Time frame: up to 8 days after last drug administration
Sponsors and collaborators
Lead sponsor
Boehringer Ingelheim
Industry
Registry information
Official study title
An Open-labelled, Randomised, 2-way Crossover Study to Compare the Pharmacokinetics of Two Different Persantin® Sugar Coated Tablets 75 mg p.o. (Present and Proposed Formulation in France) q.i.d. for Three Days in Healthy Male Volunteers
Important dates
- Study start
- 2001
- Primary completion
- 2001
- First posted
- Oct 9, 2014
- Registry last updated
- Oct 9, 2014
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Tumor-Derived FGF19
NCT06068257
Breast Cancer, Breast Diseases
Orlando, Florida, United States
View Trial DetailsAI Chatbot for HPV Vaccine Literacy Among Caregivers in Japan
NCT06702423
Healthy
London, United Kingdom
View Trial DetailsValidation of the Masimo Irregular Heartbeat Detection Algorithm in Participants Without Cardiovascular Disease
NCT07223164
Healthy
Irvine, California, United States
View Trial DetailsNormative Value for Navicular Drop Test in Older Adults
NCT05595902
Healthy
Kadıköy, Istanbul, Turkey (Türkiye)
View Trial Details