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Pharmacokinetics of Dipyridamole Administered as Aggrenox® (Dipyridamole Extended Release Plus Aspirin) Capsule Versus Dipyridamole Immediate Release Plus Aspirin Following Alteration of Stomach pH

Information source: Boehringer Ingelheim
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Aggrenox (Drug); Dipyridamole (Drug); Aspirin (Drug); Lansoprazole (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Boehringer Ingelheim

Summary

Comparison of pharmacokinetics of dipyridamole administered as Aggrenox versus dipyridamole administered as the immediate release formulation plus aspirin, under conditions of reduced stomach acidity.

Clinical Details

Official title: Comparison of Pharmacokinetics of Dipyridamole Administered as Aggrenox® (Dipyridamole Extended Release Plus Aspirin) Capsule Versus Dipyridamole Immediate Release Plus Aspirin Following Alteration of Stomach pH by the Prior Administration of a Proton-pump Inhibitor: An Open-label 2-way Randomized Cross-over Study in Healthy Male and Female Subjects Age 40-65.

Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: area under the concentration time curve (AUC0-12)

Secondary outcome:

area under the concentration time curve 0-48 hours (AUC0-48)

area under the concentration time curve extrapolated to infinity (AUC0-inf)

maximum observed plasma concentration (Cmax)

time to maximum observed plasma concentration (Tmax)

terminal half life (t1/2)

number of subjects with adverse events

number of subjects with clinically significant changes in laboratory findings

Eligibility

Minimum age: 40 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Healthy subjects as determined by results of screening

- Signed written informed consent in accordance with Good Clinical Practice (GCP) and

local legislation

- Age 40 - 65 years, inclusive, at time of Visit 1

- Stomach pH > 4. 0 on three consecutive measurements separated by at least five

minutes, measured at Visits 3B and 5B prior to dosing with Aggrenox or dipyridamole-aspirin (DP-ASA) Exclusion Criteria:

- Any findings of the medical examination (including blood pressure, pulse rate and

ECG) deviating from normal and considered by the investigator to be of clinical relevance

- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,

immunological or hormonal disorders considered by the investigator to be of clinical relevance

- History of gastro-intestinal ulcer, perforation or bleeding

- Surgery of the gastro-intestinal tract (except appendectomy)

- Diseases of the central nervous system (such as epilepsy), neurological disorders, or

psychiatric disorders

- Chronic or relevant acute infections. Screening tests will be performed for HIV,

hepatitis B, and hepatitis C

- History of hypersensitivity to Aggrenox or any of the components or excipients

- Intake of drugs with a long dominant half-life (>24 hours) 1 month or less prior to

Visit 1

- Use of any drugs which might influence the results of the trial ten days or less

prior to Visit 1

- Participation in another trial with an investigational drug 1 month or less prior to

Visit 1

- Known alcohol abuse

- Known drug abuse (a drug screening test will be performed at Visits 1, 3, and 5)

- Blood donation 1 month or less prior to Visit 1

- Excessive physical activities five days or less prior to Visit 1

- History of hemorrhagic diathesis

- History of bronchial asthma

- Any laboratory value outside the reference range, considered by the investigator to

be of clinical relevance For female subjects:

- Nursing

- Pregnancy

- Positive pregnancy test

- No adequate contraception (adequate contraception includes sterilization,

intrauterine device, or oral contraceptives)

- Inability to maintain adequate contraception during the whole study period

Locations and Contacts

Additional Information

Starting date: October 2000
Last updated: September 25, 2014

Page last updated: August 23, 2015

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