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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

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ClinicalTrials.gov Identifier: NCT02273505
Recruitment Status : Completed
First Posted : October 24, 2014
Last Update Posted : October 24, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
Comparative Pharmacokinetics of Asasantin Extended Release (ER) and of immediate release Persantin tablets combined with Acetyl salicylic acid (ASA) tablets

Condition or disease Intervention/treatment Phase
Healthy Drug: Asasantin (ER) Drug: Persantin Drug: Acetyl salicylic acid (ASA) Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : April 2000
Actual Primary Completion Date : May 2000

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Asasantin (ER) Drug: Asasantin (ER)
Active Comparator: Combination of Persantin and ASA Drug: Persantin
Drug: Acetyl salicylic acid (ASA)



Primary Outcome Measures :
  1. Area under the plasma concentration-time curve at steady state (AUCss) [ Time Frame: Up to 144 hours after drug administration ]
  2. Percentage peak trough fluctuation (%PTF) [ Time Frame: Up to 144 hours after drug administration ]

Secondary Outcome Measures :
  1. Maximum plasma concentration at steady state (Cmax,ss) of dipyridamole (dp) [ Time Frame: Up to 144 hours after drug administration ]
  2. 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 ]
  3. Time to reach maximum plasma concentration at steady state (tmax,ss) of dipyridamole [ Time Frame: Up to 144 hours after drug administration ]
  4. Fluctuation of AUC (AUCfluct) of dipyridamole [ Time Frame: Up to 144 hours after drug administration ]
  5. Terminal half-life in the analyte (t1/2) of dipyridamole [ Time Frame: Up to 144 hours after drug administration ]
  6. Urinary excretion (Ae%) of dp, dipyridamole glucuronide (dp-gluc) and salicylic acid (SA) [ Time Frame: Up to 106 hours after drug administration ]
  7. Number of participants with abnormal changes in clinical laboratory parameters [ Time Frame: Up to day 7 after last drug administration ]
  8. Number of participants with Adverse Events [ Time Frame: Up to day 7 after last drug administration ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02273505    
Other Study ID Numbers: 9.138
First Posted: October 24, 2014    Key Record Dates
Last Update Posted: October 24, 2014
Last Verified: October 2014
Additional relevant MeSH terms:
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Aspirin
Salicylic Acid
Salicylates
Dipyridamole
Aspirin, Dipyridamole Drug Combination
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Vasodilator Agents
Anti-Infective Agents
Antifungal Agents
Keratolytic Agents
Dermatologic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Fibrinolytic Agents
Fibrin Modulating Agents
Antipyretics