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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

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ClinicalTrials.gov Identifier: NCT02273531
Recruitment Status : Completed
First Posted : October 24, 2014
Last Update Posted : October 24, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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

Condition or disease Intervention/treatment Phase
Healthy Drug: Asasantin ER, new formulation Drug: Asasantin ER, present commercial formulation Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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 Start Date : January 2004
Actual Primary Completion Date : March 2004

Arm Intervention/treatment
Experimental: Asasantin ER, new formulation Drug: Asasantin ER, new formulation
Active Comparator: Asasantin ER, present commercial formulation Drug: Asasantin ER, present commercial formulation
Other Name: Aggrenox®




Primary Outcome Measures :
  1. 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 ]
  2. Maximum measured concentration of dipyridamole in plasma at steady state (Cmax,ss) [ Time Frame: up to 17 days ]

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


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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02273531    
Other Study ID Numbers: 9.149
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