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

NCT02273505 | Completed Phase 1

• 1 other identifier: 9.138
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Area under the plasma concentration-time curve at steady state (AUCss)

  Up to 144 hours after drug administration

• Percentage peak trough fluctuation (%PTF)

  Up to 144 hours after drug administration

Secondary Outcomes (8)

• Maximum plasma concentration at steady state (Cmax,ss) of dipyridamole (dp)

  Up to 144 hours after drug administration

• Maximum plasma concentration at steady state / Area under the plasma concentration-time curve at steady state ((Cmax,ss) / (AUCss)) of dipyridamole

  Up to 144 hours after drug administration

• Time to reach maximum plasma concentration at steady state (tmax,ss) of dipyridamole

  Up to 144 hours after drug administration

• Fluctuation of AUC (AUCfluct) of dipyridamole

  Up to 144 hours after drug administration

• Terminal half-life in the analyte (t1/2) of dipyridamole

  Up to 144 hours after drug administration

Study Arms (2)

Asasantin (ER)

EXPERIMENTAL

Drug: Asasantin (ER)

Combination of Persantin and ASA

ACTIVE COMPARATOR

Drug: Persantin; Drug: Acetyl salicylic acid (ASA)

Interventions

Asasantin (ER) DRUG

Asasantin (ER)

Persantin DRUG

Combination of Persantin and ASA

Acetyl salicylic acid (ASA) DRUG

Combination of Persantin and ASA

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Aspirin, Dipyridamole Drug Combination; Dipyridamole

Intervention Hierarchy (Ancestors)

Aspirin; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2014
• First Posted: October 24, 2014
• Study Start: April 1, 2000
• Primary Completion: May 1, 2000
• Last Updated: October 24, 2014

Record last verified: 2014-10