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Impact of Food on Pharmacokinetics and Pharmacodynamics of Asasantin ER in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT02273492
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 and pharmacodynamics of Asasantin ER at fasted and fed state

Condition or disease Intervention/treatment Phase
Healthy Drug: Asasantin ER Other: Standardized breakfast Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Food on Pharmacokinetics and Pharmacodynamics of Asasantin Extended Release (ER) 200/25 mg Capsules b.i.d. in a Randomized, Open, 2-way Cross-over Study in Healthy Subjects
Study Start Date : August 1999
Actual Primary Completion Date : October 1999

Arm Intervention/treatment
Experimental: Asasantin ER after a standardized breakfast Drug: Asasantin ER
Other: Standardized breakfast
Active Comparator: Asasantin ER at fasted state Drug: Asasantin ER



Primary Outcome Measures :
  1. Area under the concentration-time curve of dipyridamole in plasma at steady state (AUCss) [ Time Frame: Up to 144 hours ]
  2. Maximum concentration of dipyridamole in plasma at steady state (Cmax,ss) [ Time Frame: Up to 144 hours ]
  3. Change in Inhibition of cyclooxygenase for acetylsalicylic acid (ASA), analyte thromboxane B2 (TXB2) [ Time Frame: up to day 19 ]
  4. Maximum concentration of dipyridamole in plasma from 0 to 10h (Cmax,0-10h) [ Time Frame: up to 10 hours after drug administration ]

Secondary Outcome Measures :
  1. Ratio of peak concentration of the analytes in plasma over area under the curve at steady state (Cmax,ss / AUC,ss) [ Time Frame: Up to 144 hours ]
  2. Area under the concentration-time curve of the analyte in plasma from 0 to 10 h (AUC0-10h) [ Time Frame: Up to 10 hours after start of drug administration ]
  3. Percent peak trough fluctuation of dipyridamole in plasma (%PTF) [ Time Frame: Up to 144 hours ]
  4. Time to reach the maximum concentration of the analytes in plasma at steady state (Tmax,ss) [ Time Frame: Up to 144 hours ]
  5. Terminal half-life of the analytes in plasma (t1/2) [ Time Frame: Up to 144 hours ]
  6. Percent area under the curve fluctuation of dipyridamole in plasma (AUCfluct) [ Time Frame: Up to 144 hours ]
  7. Area under the concentration-time curve of ASA in plasma at steady state (AUCss) [ Time Frame: Up to 144 hours ]
  8. Maximum concentration of ASA in plasma at steady state (Cmax,ss) [ Time Frame: Up to 144 hours ]
  9. Change in Inhibition of cyclooxygenase for acetylsalicylic acid (ASA), analyte malondialdehyde [ Time Frame: up to day 19 ]
  10. Number of subjects with clinically significant changes in vital signs (blood pressure, pulse rate) [ Time Frame: up to day 7 ]
  11. Number of subjects with abnormal changes in laboratory parameters [ Time Frame: Up to 144 hours ]
  12. Number of subjects with adverse events [ Time Frame: up to 2 months ]


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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 written 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 disorders
  • Surgery of the gastro-intestinal tract (except appendectomy)
  • Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
  • Chronic or relevant acute infections
  • History of 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 results 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)
  • Excessive physical activities (< 5 days prior to administration)
  • History of hemorrhagic diatheses
  • History of gastro-intestinal ulcer, perforating or bleeding
  • History of bronchial asthma
  • Any laboratory value outside the normal range of clinical relevance

Female subjects:

  • Pregnancy
  • Positive pregnancy test
  • No adequate contraception (adequate contraception e.g. sterilization, intrauterine devices (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: NCT02273492     History of Changes
Other Study ID Numbers: 9.136
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, Dipyridamole Drug Combination
Platelet Aggregation Inhibitors