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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Asasantin ER; Other: Standardized breakfast

Study type: Interventional

Funder types: Industry

Identifiers

NCT02273492

9.136

Details and patient eligibility

About

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

Enrollment: 28 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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 ≥ 18 and ≤ 55 years
• Broca ≥ - 20 % and ≤ + 20 %

Exclusion criteria

• 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
• History of bronchial asthma
• Any laboratory value outside the normal range of clinical relevance

Female subjects:

• Pregnancy
• Positive pregnancy test
• No adequate contraception (adequate contraception e.g. sterilization, intrauterine devices (IUD), oral contraceptives)
• Inability to maintain this adequate contraception during the whole study period
• Lactation period

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Asasantin ER after a standardized breakfast

Experimental group

Treatment:

Drug: Asasantin ER

Other: Standardized breakfast

Asasantin ER at fasted state

Active Comparator group

Treatment:

Drug: Asasantin ER