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OpenTrials
Completed

NCT Number: NCT02273557

Bioavailability of Dipyridamole of Asasantin p.o. in Three Experimental Formulations Relative to the Standard Formulation in Healthy Male Subjects

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 BID treatment

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Key information

Conditions

Age range

50 year and older

Sex eligibility

Male

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 male subjects as determined by results of screening
  • Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
  • Age >=50 years
  • BMI >=18.5 and <=29.9 kg/m2
  • 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 is 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 (< 3 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
  • 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

Treatment and study plan

Asasantin ER (new formulation I - low)

Drug

Asasantin ER (new formulation III - medium)

Drug

Asasantin ER (new formulation II - high)

Drug

Asasantin ER (present commercial formulation)

Drug

Primary outcomes

  1. Urinary excretion of dipyridamole

    Time frame: day 2, day 3

    represented by the sum of percentage of amount excreted from time zer0 to 10 h (%Ae 0-10 h), %Ae 10-24h

Secondary outcomes

  1. 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

  2. Cmin urine (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

  3. %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

  4. Number of subjects with adverse events

    Time frame: up to 23 days

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Bioavailability of Dipyridamole of Asasantin p.o. (Extended Release 200 mg Dipyridamole/25 mg ASA) in Three Experimental Formulations (Given BID Over 3 Days Each) Relative to the Standard Formulation After a run-in Phase (Persantine ER BID for 2 Days Each: 25 mg, 50 mg, 100 mg; 150 mg [Persantine®]; 200 mg Persantine/25 mg ASA [Asasantin ER] in Healthy Male Subjects. Four-way, Change-over, Randomised, Open

Important dates

Study start
2003
Primary completion
2003
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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