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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Asasantin ER, new formulation; Drug: Asasantin ER, present commercial formulation

• Registration Number: NCT02273531
• Lead Sponsor: 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®)

Detailed Description

Not available

Study Timeline

• Study Start: 2004-01
• Primary Completion: 2004-03
• Status Verified: 2014-10
• Study First Submitted: 2014-10-23
• Study First Submitted QC: 2014-10-23
• Last Update Submitted: 2014-10-23
• Study First Posted: 2014-10-24
• Last Update Posted: 2014-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Asasantin ER, new formulation	Asasantin ER, new formulation	-
Asasantin ER, present commercial formulation	Asasantin ER, present commercial formulation	-

Primary Outcome Measures

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

Secondary Outcome Measures

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