NCT Number: NCT02273505
Comparison of Pharmacokinetics of Dipyridamole in Asasantin Extended Release (ER) and in a Combination of Persantin Immediate Release Tablets and ASA Tablets in Healthy Subjects
Comparative Pharmacokinetics of Asasantin Extended Release (ER) and of immediate release Persantin tablets combined with Acetyl salicylic acid (ASA) tablets
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Conditions
Age range
18 year–55 year
Sex eligibility
All sexes
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
- Healthy subjects as determined by results of screening
- Signed informed consent in accordance with Good Clinical Practice (GCP) and local legislation
- Age >= 18 and <= 55 years
- Broca >= - 20% and <= + 20%
Exclusion criteria
- Any findings 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 disorder
- Surgery of the gastro-intestinal tract (except appendectomy)
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- Chronic or relevant acute infections
- History or hypersensitivity to Asasantin ER and any of the excipients
- Intake of drugs with a long half-life (> 24 hours) (<= 1 month prior to administration or during the trial)
- Use of any drugs which might influence the result of the trial (<= 10 days prior to administration or during the trial)
- Participation in another trial with an investigational drug (<= 1 month prior to administration or during the trial)
- Known alcohol abuse
- Known drug abuse
- Blood donation ( <=1 month prior to administration or during the trial)
- Excessive physical activities (<=5 days prior to administration or during the trial)
- History of hemorrhagic diseases
- History of gastro-intestinal ulcer, perforation or bleeding
- History of bronchial asthma
- Any laboratory value outside the reference range of clinical relevance
For female subjects:
- Pregnancy
- Positive pregnant test
- No adequate contraception (adequate contraception e.g. sterilization, intrauterine device (IUD), oral contraceptives)
- Inability to maintain this adequate contraception during the whole study period
- Lactation period
Treatment and study plan
Persantin
DrugAcetyl salicylic acid (ASA)
DrugPrimary outcomes
-
Area under the plasma concentration-time curve at steady state (AUCss)
Time frame: Up to 144 hours after drug administration
-
Percentage peak trough fluctuation (%PTF)
Time frame: Up to 144 hours after drug administration
Secondary outcomes
-
Maximum plasma concentration at steady state (Cmax,ss) of dipyridamole (dp)
Time frame: Up to 144 hours after drug administration
-
Maximum plasma concentration at steady state / Area under the plasma concentration-time curve at steady state ((Cmax,ss) / (AUCss)) of dipyridamole
Time frame: Up to 144 hours after drug administration
-
Time to reach maximum plasma concentration at steady state (tmax,ss) of dipyridamole
Time frame: Up to 144 hours after drug administration
-
Fluctuation of AUC (AUCfluct) of dipyridamole
Time frame: Up to 144 hours after drug administration
-
Terminal half-life in the analyte (t1/2) of dipyridamole
Time frame: Up to 144 hours after drug administration
-
Urinary excretion (Ae%) of dp, dipyridamole glucuronide (dp-gluc) and salicylic acid (SA)
Time frame: Up to 106 hours after drug administration
-
Number of participants with abnormal changes in clinical laboratory parameters
Time frame: Up to day 7 after last drug administration
-
Number of participants with Adverse Events
Time frame: Up to day 7 after last drug administration
Sponsors and collaborators
Lead sponsor
Boehringer Ingelheim
Industry
Registry information
Official study title
Comparison of Pharmacokinetics of Dipyridamole in Asasantin Extended Release (ER) 200/25 mg Capsules Bid and in a Combination of Persantin Immediate Release Tablets (100 mg Qid) and ASA Tablets (25 mg Bid) in an Open, Randomized, 2-way Crossover Study in Healthy Subjects
Important dates
- Study start
- 2000
- Primary completion
- 2000
- First posted
- Oct 24, 2014
- Registry last updated
- Oct 24, 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.
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