Relative Bioavailability of Telmisartan and SR26334 After Co-administration Compared to the Bioavailability of Telmisartan and SR26334 After Administration of Telmisartan and Clopidogrel Alone in Healthy Male and Female Subjects

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Telmisartan; Drug: Clopidogrel

Study type: Interventional

Funder types: Industry

Identifiers

NCT02262650

502.457

Details and patient eligibility

About

Study to investigate the relative bioavailability of concomitant administration of clopidogrel and telmisartan (Test 1) relative to the bioavailability of SR26334 alone (Reference 1), and relative to the bioavailability of telmisartan alone (Reference 2). And to investigate the bioavailability of SR26334 following administration of clopidogrel 30 minutes after intake of telmisartan (Test 2) relative to the bioavailability of SR26334 alone (Reference 1), and relative to the bioavailability of telmisartan alone (Reference 2)

Enrollment: 24 patients

Sex: All

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male and female subjects according to the following criteria: based upon a complete medical history, the physical examination, vital signs (BP, HR), 12-lead ECG, clinical laboratory tests
• Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation
• Age >= 40 years
• Body Mass Index (BMI) >=18.5 and <=29.9 kg/m2
• Good venous status of forearms

Exclusion criteria

• Any finding of the medical examination (including blood pressure, heart 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 relevant orthostatic hypotension, fainting spells or blackouts
• Chronic or relevant acute infections
• History of an allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
• Intake of drugs with a long half-life (> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
• Use of any drugs, which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
• Participation in another trial with an investigational drug within two months prior to administration or during the trial
• Smoker (more than 10 cigarettes or three cigars or three pipes/day)
• Alcohol abuse (more than 60 g/day)
• Drug abuse
• Blood donation or loss of more than 400 mL within four weeks prior to administration or during the trial.
• Excessive physical activities (within five days prior to administration or during the trial)
• Any laboratory value outside the reference range of clinical relevance
• History of hereditary fructose intolerance
• Veins unsuited for i.v. puncture on either arm (e.g. veins which are difficult to locate, access or puncture, veins with a tendency to rupture during or after puncture, etc.)
• Inability to comply with the dietary regimen of study centre
• Inability to comply with the investigators instructions

For female subjects:

• Pregnancy
• Positive pregnancy test
• No adequate contraception e.g. oral contraceptives, sterilization, intrauterine device (IUD)
• 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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24 participants in 4 patient groups

Telmisartan alone

Active Comparator group

Treatment:

Drug: Telmisartan

Telmisartan + Clopidogrel (concomitantly)

Experimental group

Treatment:

Drug: Clopidogrel

Drug: Telmisartan

Telmisartan + Clopidogrel (consecutively)

Experimental group

Treatment:

Drug: Clopidogrel

Drug: Telmisartan

Clopidogrel alone

Active Comparator group

Treatment:

Drug: Clopidogrel