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

Healthy Clinical Trial

Official title:

Bioavailability of Dipyridamole After Asasantin (Extended Release 200mg Dipyridamole/25mg ASA) in 3 Experimental Formulations (Given b.i.d. Over 3 or 5 Days, Respectively) Relative to the Standard Formulation in 16 Healthy Female and Male Subjects. Intraindividual Comparison, Randomised, Open

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02273544
• Other study ID #: 9.158
• Status: Terminated
• Phase: Phase 1
• First received: October 23, 2014
• Last updated: October 23, 2014
• Start date: September 2002

Study information

• Verified date: October 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. primary completion date: October 2002
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• Blood donation or loss > 400 mL (< 1 month prior to administration or during the trial)

• Excessive physical activities (< 5 days prior to administration or during the trial)

• Any ECG value outside of the reference range of clinical relevance including, but not limited to QTcB > 480 ms or QRS interval > 110 ms

• History of any familial bleeding disorder

• Inability to comply with dietary regimen of study centre

• Inability to comply with investigator's instructions

For Female Subjects:

• Pregnancy

• Positive pregnancy test

• No adequate contraception (adequate contraception e.g. sterilization, Intrauterine Pessary (IUP), oral contraceptives)

• Inability to maintain this adequate contraception during the whole study period

• Lactation period

During the interval between screening and start of drug administration tobacco and caffeine are restricted to avoid withdrawal when starting medication. As no relevant influence on Pharmacokinetic parameters is known moderate tobacco and caffeine consumption are allowed to facilitate trial participation (up to 10 cigarettes or 3 cigars or 3 pipes/day, and/or up to three cups of coffee respectively). Ovarian hormone substitution and oral contraception are allowed to be continued during the study

Study Design

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Asasantin ER (new formulation - low)

• Asasantin ER (new formulation - medium)

• Asasantin ER (new formulation - high)

• Asasantin ER - commercial formulation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary excretion of dipyridamole	geometric means of percentage of amount excreted from time zero to 10 h (% Ae 0-10h)	day 2, day 3	No
Secondary	Cmax urine (Maximum measured concentration of the analyte)	Urine collected fraction from 0 -3 hours as surrogate for Cmax	0 to 3 hours after drug intake	No
Secondary	Cmin (Minimum measured concentration of the analyte)	Urine collected fraction from 8 - 10 hours as surrogate for Cmin	8 - 10 hours after drug intake	No
Secondary	% PTF urine (peak trough fluctuation)	Estimated from the difference of percentage amount excreted from 1 - 3 hours (%Ae (1-3hours) and %Ae (8-10 hours) divided by the average excretion rate over the total dosing interval	Up to 10 hours after drug intake	No
Secondary	Number of subjects with adverse events		up to 1 month	No

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