Study to Evaluate Pharmacokinetics of Dipyridamole in Three New Formulations of Asasantin ER in Healthy Female and Male Subjects

NCT02273544 | Terminated Phase 1

• 1 other identifier: 9.158
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this study was to compare the pharmacokinetics of dipyridamole in three different Asasantin ER batches (test) containing different amounts of retarding lacquers to the existing commercial product at steady state with b.i.d. treatment

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Urinary excretion of dipyridamole

  geometric means of percentage of amount excreted from time zero to 10 h (% Ae 0-10h)

  day 2, day 3

Secondary Outcomes (4)

• Cmax urine (Maximum measured concentration of the analyte)

  0 to 3 hours after drug intake

• Cmin (Minimum measured concentration of the analyte)

  8 - 10 hours after drug intake

• % PTF urine (peak trough fluctuation)

  Up to 10 hours after drug intake

• Number of subjects with adverse events

  up to 1 month

Study Arms (4)

Asasantin ER (new formulation - low)

EXPERIMENTAL

Drug: Asasantin ER (new formulation - low)

Asasantin ER (new formulation - medium)

EXPERIMENTAL

Drug: Asasantin ER (new formulation - medium)

Asasantin ER (new formulation- high)

EXPERIMENTAL

Drug: Asasantin ER (new formulation - high)

Asasantin ER - commercial formulation

ACTIVE COMPARATOR

Drug: Asasantin ER - commercial formulation

Interventions

Asasantin ER (new formulation - low) DRUG

Asasantin ER (new formulation - low)

Asasantin ER (new formulation - medium) DRUG

Asasantin ER (new formulation - medium)

Asasantin ER (new formulation - high) DRUG

Asasantin ER (new formulation- high)

Asasantin ER - commercial formulation DRUG

Asasantin ER - commercial formulation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male or female subjects as determined by results of screening
• Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
• Female subjects are not lactating. Females must use adequate contraception (adequate contraception e.g. sterilization, IUP, oral contraceptives) prior to administration of study medication, during the study until after release from the study. Women must have negative blood pregnancy tests
• Age \>= 18 and \<= 60 years
• BMI \>=18.5 and \<=29.9 kg/m2 (see abbreviations for formula)
• Able to communicate well with the investigator and to comply with study requirements
• Laboratory values within a clinically defined reference range

You may not qualify if:

• Any finding of the medical examination (including blood pressure, pulse rate, and electrocardiogram) deviating from normal and of clinical relevance
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic 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 orthostatic hypotension, fainting spells or blackouts
• Chronic or relevant acute infections
• History of allergy/hypersensitivity (including drug allergy) which were deemed relevant to the trial as judged by the investigator
• Intake of drugs with a long half-life (\> 24 hours) (\< 1 month prior to administration or during the trial)
• Use of any drugs, which might influence the results of the trial, (\< 10 days prior to administration or during the trial)
• Participation in another trial with an investigational drug (\< 1 months prior to administration (at least 10 times the relevant elimination half-life) or during trial)
• Having had prescription medication 2 weeks prior to study drug administration or over the counter medication 1 week prior to study drug administration (at least 10 times the relevant elimination half-life)
• Smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day)
• Alcohol abuse (\> 60 g/day)
• Drug abuse
• Use of methylxanthine-containing drinks or foods (coffee, tea, cola, energy drinks, chocolate, etc.), grapefruit or grapefruit juice, alcohol, green tea, or tobacco \< 5 days prior to administration of study drug

Sponsors & Collaborators

• Boehringer Ingelheim: lead

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: September 1, 2002
• Primary Completion: October 1, 2002
• Last Updated: October 24, 2014

Record last verified: 2014-10