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

NCT02262650 | Completed Phase 1

• 1 other identifier: 502.457
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

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)

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• AUC0-∞ (area under the concentration time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)

  up to 72 hours post dose

• Cmax (maximum concentration of the analyte in plasma)

  up to 72 hours post dose

Secondary Outcomes (12)

• Number of subjects with adverse events

  up to 8 days after last drug administration

• Number of subjects with clinically significant findings in vital signs

  up to 8 days after last drug administration

• Number of subjects with clinically significant findings in ECG

  up to 8 days after last drug administration

• Number of subjects with clinically significant findings in labortory test

  up to 8 days after last drug administration

• tmax (time from dosing to the maximum concentration of the analyte in plasma)

  up to 72 hours post dose

Study Arms (4)

Telmisartan alone

ACTIVE COMPARATOR

Drug: Telmisartan

Telmisartan + Clopidogrel (concomitantly)

EXPERIMENTAL

Drug: Telmisartan; Drug: Clopidogrel

Telmisartan + Clopidogrel (consecutively)

EXPERIMENTAL

Drug: Telmisartan; Drug: Clopidogrel

Clopidogrel alone

ACTIVE COMPARATOR

Drug: Clopidogrel

Interventions

Telmisartan DRUG

Telmisartan + Clopidogrel (concomitantly); Telmisartan + Clopidogrel (consecutively); Telmisartan alone

Clopidogrel DRUG

Clopidogrel alone; Telmisartan + Clopidogrel (concomitantly); Telmisartan + Clopidogrel (consecutively)

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Telmisartan; Clopidogrel

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

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 10, 2014
• First Posted: October 13, 2014
• Study Start: April 1, 2004
• Primary Completion: May 1, 2004
• Last Updated: October 13, 2014

Record last verified: 2014-10