Clinical trial NCT02273531: 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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-10-24
Enrollment: 24
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Area under the concentration-time curve of dipyridamole in plasma over one dosing interval at steady state (AUCτ,ss)
timeFrame: up to 17 days
measure: Maximum measured concentration of dipyridamole in plasma at steady state (Cmax,ss)
timeFrame: up to 17 days
Secondary outcomes:
measure: Minimum measured concentration of dipyridamole in plasma at steady state (Cmin,ss)
timeFrame: up to 17 days
measure: Average concentration of dipyridamole in plasma at steady state (Cavg)
timeFrame: up to 17 days
measure: Time from dosing to the maximum concentration of dipyridamole in plasma at steady state (tmax,ss)
timeFrame: up to 17 days
measure: Peak trough fluctuation of dipyridamole in plasma (PTF)
timeFrame: up to 17 days
measure: Amount of the analytes that were eliminated in urine (Ae)
timeFrame: up to 24 hours after drug administration
measure: Fraction in percent of dose of the analytes that was eliminated in urine (fe)
timeFrame: up to 24 hours after drug administration
measure: Number of subjects with clinically significant changes in 12-lead ECG
timeFrame: up to 17 days
measure: Number of subjects with clinically significant changes in vital signs (blood pressure, pulse rate)
timeFrame: up to 17 days
measure: Number of subjects with clinically significant changes in laboratory tests
timeFrame: up to 17 days
measure: Number of subjects with adverse events
timeFrame: up to 17 days
measure: Assessment of tolerability by the investigator on a 4-point scale
timeFrame: after 17 days
Other outcomes:
Locations:
Study officials:
References: