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Study to Evaluate Pharmacokinetics of Dipyridamole in Three New Formulations of Asasantin ER in Healthy Female and Male Subjects

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ClinicalTrials.gov Identifier: NCT02273544
Recruitment Status : Terminated
First Posted : October 24, 2014
Last Update Posted : October 24, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE October 23, 2014
First Posted Date  ICMJE October 24, 2014
Last Update Posted Date October 24, 2014
Study Start Date  ICMJE September 2002
Actual Primary Completion Date October 2002   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 23, 2014)
Urinary excretion of dipyridamole [ Time Frame: day 2, day 3 ]
geometric means of percentage of amount excreted from time zero to 10 h (% Ae 0-10h)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 23, 2014)
  • Cmax urine (Maximum measured concentration of the analyte) [ Time Frame: 0 to 3 hours after drug intake ]
    Urine collected fraction from 0 -3 hours as surrogate for Cmax
  • Cmin (Minimum measured concentration of the analyte) [ Time Frame: 8 - 10 hours after drug intake ]
    Urine collected fraction from 8 - 10 hours as surrogate for Cmin
  • % PTF urine (peak trough fluctuation) [ Time Frame: Up to 10 hours after drug intake ]
    Estimated from the difference of percentage amount excreted from 1 - 3 hours (%Ae (1-3hours) and %Ae (8-10 hours) divided by the average excretion rate over the total dosing interval
  • Number of subjects with adverse events [ Time Frame: up to 1 month ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate Pharmacokinetics of Dipyridamole in Three New Formulations of Asasantin ER in Healthy Female and Male Subjects
Official Title  ICMJE Bioavailability of Dipyridamole After Asasantin (Extended Release 200mg Dipyridamole/25mg ASA) in 3 Experimental Formulations (Given b.i.d. Over 3 or 5 Days, Respectively) Relative to the Standard Formulation in 16 Healthy Female and Male Subjects. Intraindividual Comparison, Randomised, Open
Brief Summary The objective of this study was to compare the pharmacokinetics of dipyridamole in three different Asasantin ER batches (test) containing different amounts of retarding lacquers to the existing commercial product at steady state with b.i.d. treatment
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Asasantin ER (new formulation - low)
  • Drug: Asasantin ER (new formulation - medium)
  • Drug: Asasantin ER (new formulation - high)
  • Drug: Asasantin ER - commercial formulation
Study Arms  ICMJE
  • Experimental: Asasantin ER (new formulation - low)
    Intervention: Drug: Asasantin ER (new formulation - low)
  • Experimental: Asasantin ER (new formulation - medium)
    Intervention: Drug: Asasantin ER (new formulation - medium)
  • Experimental: Asasantin ER (new formulation- high)
    Intervention: Drug: Asasantin ER (new formulation - high)
  • Active Comparator: Asasantin ER - commercial formulation
    Intervention: Drug: Asasantin ER - commercial formulation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 23, 2014)
16
Original Actual Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date October 2002   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male or female subjects as determined by results of screening
  • Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
  • Female subjects are not lactating. Females must use adequate contraception (adequate contraception e.g. sterilization, IUP, oral contraceptives) prior to administration of study medication, during the study until after release from the study. Women must have negative blood pregnancy tests
  • Age >= 18 and <= 60 years
  • BMI >=18.5 and <=29.9 kg/m2 (see abbreviations for formula)
  • Able to communicate well with the investigator and to comply with study requirements
  • Laboratory values within a clinically defined reference range

Exclusion Criteria:

  • Any finding of the medical examination (including blood pressure, pulse rate, and electrocardiogram) deviating from normal and of clinical relevance
  • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic or hormonal disorders
  • Surgery of gastrointestinal tract (except appendectomy)
  • 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 were deemed relevant to the trial as judged by the investigator
  • 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 months prior to administration (at least 10 times the relevant elimination half-life) or during trial)
  • Having had prescription medication 2 weeks prior to study drug administration or over the counter medication 1 week prior to study drug administration (at least 10 times the relevant elimination half-life)
  • Smoker (> 10 cigarettes or 3 cigars or 3 pipes/day)
  • Alcohol abuse (> 60 g/day)
  • Drug abuse
  • Use of methylxanthine-containing drinks or foods (coffee, tea, cola, energy drinks, chocolate, etc.), grapefruit or grapefruit juice, alcohol, green tea, or tobacco < 5 days prior to administration of study drug
  • Blood donation or loss > 400 mL (< 1 month prior to administration or during the trial)
  • Excessive physical activities (< 5 days prior to administration or during the trial)
  • Any ECG value outside of the reference range of clinical relevance including, but not limited to QTcB > 480 ms or QRS interval > 110 ms
  • History of any familial bleeding disorder
  • Inability to comply with dietary regimen of study centre
  • Inability to comply with investigator's instructions

For Female Subjects:

  • Pregnancy
  • Positive pregnancy test
  • No adequate contraception (adequate contraception e.g. sterilization, Intrauterine Pessary (IUP), oral contraceptives)
  • Inability to maintain this adequate contraception during the whole study period
  • Lactation period

During the interval between screening and start of drug administration tobacco and caffeine are restricted to avoid withdrawal when starting medication. As no relevant influence on Pharmacokinetic parameters is known moderate tobacco and caffeine consumption are allowed to facilitate trial participation (up to 10 cigarettes or 3 cigars or 3 pipes/day, and/or up to three cups of coffee respectively). Ovarian hormone substitution and oral contraception are allowed to be continued during the study

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02273544
Other Study ID Numbers  ICMJE 9.158
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Boehringer Ingelheim
Verification Date October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP