Bioequivalence of a New Asasantin Formulation Extended Release (ER) Compared to the Commercially Available Asasantin Formulation (Aggrenox®; Extended Release) in Healthy Male and Female Volunteers

October 23, 2014 updated by: Boehringer Ingelheim

Bioequivalence of a New Asasantin Capsule Formulation (Extended Release Combination 200 mg Dipyridamole/25 mg ASA) Compared to the Commercially Available Asasantin Capsule Formulation (Aggrenox®; Extended Release Combination 200 mg Dipyridamole/25 mg ASA) Following Multiple Oral Administration at Steady State After a run-in Phase (Persantine ER BID for 2 Days Each: 25 mg, 50 mg, 100 mg, 150 mg [Persantine®]; 200 mg Dipyridamole/25 mg ASA [Asasantin ER])- an Open Label, Randomized, Multiple-dose, Two-way Crossover, Change-over Study in Healthy Male and Female Volunteers

Study to establish the bioequivalence of a new formulation of Asasantin ER compared to the present commercially available Asasantin ER formulation (Aggrenox®)

Study Overview

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Based upon a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead ECG, clinical laboratory tests:

    • No finding deviating from normal and of clinical relevance
    • No evidence of a clinically relevant concomitant disease
  • Age ≥ 21 and ≤ 65 years
  • Body mass index (BMI) ≥ 18.5 and ≤ 29.9 kg/m2
  • Signed and dated written informed consent prior to admission to the study in accordance with good clinical practice (GCP) and the local legislation
  • Able to communicate well with the investigator and to comply with study requirements

Exclusion Criteria:

  • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological 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 relevant 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) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
  • Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 14 days prior to administration or during the trial
  • Participation in another trial with an investigational drug within two months prior to administration or during the trial
  • Smoker (more than 10 cigarettes or 3 cigars or 3 pipes/day)
  • Inability to refrain from smoking on trial days Alcohol abuse (more than 60 g/day)
  • Drug abuse
  • Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
  • Excessive physical activities (within one week prior to administration or during the trial)
  • Any laboratory value outside the reference range that is of clinical relevance
  • Inability to comply with dietary regimen of study centre
  • History of frequent headaches
  • History of gastro-intestinal ulcer disease

For female subjects:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Asasantin ER, new formulation
Active Comparator: Asasantin ER, present commercial formulation
Other Names:
  • Aggrenox®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area under the concentration-time curve of dipyridamole in plasma over one dosing interval at steady state (AUCτ,ss)
Time Frame: up to 17 days
up to 17 days
Maximum measured concentration of dipyridamole in plasma at steady state (Cmax,ss)
Time Frame: up to 17 days
up to 17 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Minimum measured concentration of dipyridamole in plasma at steady state (Cmin,ss)
Time Frame: up to 17 days
up to 17 days
Average concentration of dipyridamole in plasma at steady state (Cavg)
Time Frame: up to 17 days
up to 17 days
Time from dosing to the maximum concentration of dipyridamole in plasma at steady state (tmax,ss)
Time Frame: up to 17 days
up to 17 days
Peak trough fluctuation of dipyridamole in plasma (PTF)
Time Frame: up to 17 days
up to 17 days
Amount of the analytes that were eliminated in urine (Ae)
Time Frame: up to 24 hours after drug administration
up to 24 hours after drug administration
Fraction in percent of dose of the analytes that was eliminated in urine (fe)
Time Frame: up to 24 hours after drug administration
up to 24 hours after drug administration
Number of subjects with clinically significant changes in 12-lead ECG
Time Frame: up to 17 days
up to 17 days
Number of subjects with clinically significant changes in vital signs (blood pressure, pulse rate)
Time Frame: up to 17 days
up to 17 days
Number of subjects with clinically significant changes in laboratory tests
Time Frame: up to 17 days
up to 17 days
Number of subjects with adverse events
Time Frame: up to 17 days
up to 17 days
Assessment of tolerability by the investigator on a 4-point scale
Time Frame: after 17 days
after 17 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Primary Completion (Actual)

March 1, 2004

Study Registration Dates

First Submitted

October 23, 2014

First Submitted That Met QC Criteria

October 23, 2014

First Posted (Estimate)

October 24, 2014

Study Record Updates

Last Update Posted (Estimate)

October 24, 2014

Last Update Submitted That Met QC Criteria

October 23, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • 9.149

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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