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

NCT02273531 | Completed Phase 1

• 1 other identifier: 9.149
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (11)

• 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

Study Arms (2)

Asasantin ER, new formulation

EXPERIMENTAL

Drug: Asasantin ER, new formulation

Asasantin ER, present commercial formulation

ACTIVE COMPARATOR

Drug: Asasantin ER, present commercial formulation

Interventions

Asasantin ER, new formulation DRUG

Asasantin ER, new formulation

Asasantin ER, present commercial formulation DRUG

Also known as: Aggrenox®

Asasantin ER, present commercial formulation

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Aspirin, Dipyridamole Drug Combination

Intervention Hierarchy (Ancestors)

Aspirin; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Dipyridamole; 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: January 1, 2004
• Primary Completion: March 1, 2004
• Last Updated: October 24, 2014

Record last verified: 2014-10