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OpenTrials
Completed

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

Completed

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Key information

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

Asasantin (ER)

Drug

Persantin

Drug

Acetyl salicylic acid (ASA)

Drug

Primary outcomes

  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 outcomes

  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

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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