Impact of Food on Pharmacokinetics and Pharmacodynamics of Asasantin ER in Healthy Subjects

NCT02273492 | Completed Phase 1

• 1 other identifier: 9.136
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

Brief Summary

Comparative pharmacokinetics and pharmacodynamics of Asasantin ER at fasted and fed state

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

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

  Up to 144 hours

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

  Up to 144 hours

• Change in Inhibition of cyclooxygenase for acetylsalicylic acid (ASA), analyte thromboxane B2 (TXB2)

  up to day 19

• Maximum concentration of dipyridamole in plasma from 0 to 10h (Cmax,0-10h)

  up to 10 hours after drug administration

Secondary Outcomes (12)

• Ratio of peak concentration of the analytes in plasma over area under the curve at steady state (Cmax,ss / AUC,ss)

  Up to 144 hours

• Area under the concentration-time curve of the analyte in plasma from 0 to 10 h (AUC0-10h)

  Up to 10 hours after start of drug administration

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

  Up to 144 hours

• Time to reach the maximum concentration of the analytes in plasma at steady state (Tmax,ss)

  Up to 144 hours

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

  Up to 144 hours

Study Arms (2)

Asasantin ER after a standardized breakfast

EXPERIMENTAL

Drug: Asasantin ER; Other: Standardized breakfast

Asasantin ER at fasted state

ACTIVE COMPARATOR

Drug: Asasantin ER

Interventions

Asasantin ER DRUG

Asasantin ER after a standardized breakfast; Asasantin ER at fasted state

Standardized breakfast OTHER

Asasantin ER after a standardized breakfast

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy subjects as determined by results of screening
• Signed written informed consent in accordance with good clinical practice (GCP) and local legislation
• Age ≥ 18 and ≤ 55 years
• Broca ≥ - 20 % and ≤ + 20 %

You may not qualify if:

• Any findings of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Surgery of the gastro-intestinal tract (except appendectomy)
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
• Chronic or relevant acute infections
• History of hypersensitivity to Asasantin ER and any of the excipients
• 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 month prior to administration or during the trial)
• Known alcohol abuse
• Known drug abuse
• Blood donation (\< 1 month prior to administration)
• Excessive physical activities (\< 5 days prior to administration)
• History of hemorrhagic diatheses
• History of gastro-intestinal ulcer, perforating or bleeding

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: August 1, 1999
• Primary Completion: October 1, 1999
• Last Updated: October 24, 2014

Record last verified: 2014-10