Study to Compare the Pharmacokinetics of Dipyridamole in Three Different Asasantin Extended Release (ER) Formulations in Healthy Male and Female Volunteers

NCT02273518 | Completed Phase 1

• 1 other identifier: 9.144
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief Summary

Comparative pharmacokinetics of dipyridamole in two new formulations of Asasantin ER compared to the present commercial formulation

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Area under the concentration-time curve of dipyridamole in plasma at steady state (AUC,ss)

  Up to 48 hours after start of drug administration

• Percent peak trough fluctuation of dipyridamole in plasma (%PTF)

  Up to 48 hours after start of drug administration

Secondary Outcomes (11)

• Maximum concentration of the analytes in plasma at steady state (Cmax,ss)

  Up to 48 hours after start of drug administration

• Minimum measured concentration of the analytes in plasma at steady state over a uniform dosing interval τ (Cmin,ss)

  Up to 48 hours after start of drug administration

• Time from dosing to the maximum measured concentration of the analytes in plasma at steady state over a uniform dosing interval τ Time from dosing to the maximum measured concentration of the analytes in plasma at steady state (tmax,ss)

  Up to 48 hours after start of drug administration

• Percent area under the curve fluctuation of the analytes in plasma (AUCfluct)

  Up to 48 hours after start of drug administration

• Terminal half-life of the analytes in plasma (t1/2)

  Up to 48 hours after start of drug administration

Study Arms (3)

Asasantin ER, new formulation I

EXPERIMENTAL

Drug: Asasantin ER, new formulation I

Asasantin ER, new formulation II

EXPERIMENTAL

Drug: Asasantin ER, new formulation II

Asasantin ER, present commercial formulation

ACTIVE COMPARATOR

Drug: Asasantin ER, present commercial formulation

Interventions

Asasantin ER, new formulation I DRUG

Asasantin ER, new formulation I

Asasantin ER, new formulation II DRUG

Asasantin ER, new formulation II

Asasantin ER, present commercial formulation DRUG

Asasantin ER, present commercial formulation

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• All participants in the study should be healthy males or females, range from 21 to 50 years of age and be within ± 20 % of their normal weight (Broca-Index)
• Prior to admission to the study all volunteers will have given, in accordance with good clinical practice (GCP) and the local legislation, their written informed consent
• Subsequently each subject will have his medical history taken and will receive a complete medical examination (incl. blood pressure and pulse rate measurements) as well as a 12-lead ECG
• Hematopoietic, hepatic and renal function tests will be carried out in the laboratory
• The subjects will fast for 12 hours before collection of specimens for all laboratory evaluations
• The above mentioned examinations will be performed within 14 days before the first administration of the test substance

You may not qualify if:

• Volunteers are excluded from the study if the results of the medical examination or laboratory tests are judged by the clinical investigator to differ significantly from normal clinical values
• Subjects with known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Subjects with diseases of the central nervous system (such as epilepsy) or with psychiatric or neurological disorders
• History of orthostatic hypotension, fainting spells or blackouts
• Subjects with chronic or relevant acute infections
• Subjects with allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
• Volunteers who have taken a drug with a long half-life (≥ 24 hours) within one month or less than ten half-lives of the respective drug before enrolment in the study
• Volunteers who receive any other drugs which might influence the results of the trial during the week previous to enrolment in the study
• Volunteers who participate in another study with an investigational drug within the last two months preceding the study
• Volunteers who are unable to refrain from smoking on study days
• Volunteers who smoke more than10 cigarettes (or equivalent) per day
• Volunteers who drink more than 60 g of alcohol per day
• Volunteers who are dependent on drugs
• Volunteers who donate blood (≥ 100 mL) within the last four weeks
• Volunteers who participate in excessive physical activities within the last week before the study (e.g. competitive sports)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• 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: April 1, 2001
• Primary Completion: May 1, 2001
• Last Updated: October 24, 2014

Record last verified: 2014-10