Relative Bioavailability of Telmisartan and Dipyridamole After Co-administration Compared to the Bioavailability of Telmisartan or Dipyridamole Alone in Healthy Female and Male Subjects

NCT02262793 | Completed Phase 1

• 1 other identifier: 502.458
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

To investigate the relative bioavailability of telmisartan respectively of dipyridamole after concomitant administration of 80 mg telmisartan in Micardis® and 25 mg acetylsalicylic acid (ASA)/200 mg extended release (ER) dipyridamole (DP) in Aggrenox® (Test 1) relative to ER-DP in Aggrenox® alone (Reference 1), respectively relative to telmisartan in Micardis® alone (Reference 2). To investigate the relative bioavailability of dipyridamole respectively of telmisartan administered as 25 mg ASA/200 mg ER-DP 30 minutes after intake of 80 mg telmisartan (Test 2) relative to dipyridamole in Aggrenox® alone (Reference 1), respectively relative to telmisartan in Micardis® alone (Reference 2).

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

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

  up to 72 hours following drug administration

• Cmax (maximum concentration in plasma)

  up to 72 hours following drug administration

Secondary Outcomes (13)

• AUC0-tz (area under the concentration-time curve in plasma over the time interval from 0 to the time of the last quantifiable data point)

  up to 72 hours following drug administration

• AUCt1-t2 (Area under the concentration time curve in plasma over the time interval t1 to t2)

  up to 72 hours following drug administration

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

  up to 72 hours following drug administration

• λz (terminal rate constant in plasma)

  up to 72 hours following drug administration

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

  up to 72 hours following drug administration

Study Arms (4)

telmisartan and ASA/ER-DP (concomitant)

EXPERIMENTAL

Drug: telmisartan; Drug: ASA/ER-DP

ASA/ER-DP alone

ACTIVE COMPARATOR

Drug: ASA/ER-DP

telmisartan and ASA/ER-DP (consecutively)

EXPERIMENTAL

Drug: telmisartan; Drug: ASA/ER-DP

telmisartan

ACTIVE COMPARATOR

Drug: telmisartan

Interventions

telmisartan DRUG

telmisartan; telmisartan and ASA/ER-DP (concomitant); telmisartan and ASA/ER-DP (consecutively)

ASA/ER-DP DRUG

ASA/ER-DP alone; telmisartan and ASA/ER-DP (concomitant); telmisartan and ASA/ER-DP (consecutively)

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy females and males according to the following criteria:
• Based upon a complete medical history, including the physical examination, vital signs (BP, HR), 12-lead ECG, clinical laboratory tests
• No finding deviating from normal and of clinical relevance
• No evidence of a clinically relevant concomitant disease
• Age ≥21 and Age ≤65 years
• BMI ≥18.5 and BMI ≤29.9 kg/m2 (Body Mass Index)
• Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation

You may not qualify if:

• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological 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 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 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/day or 3 cigars/day or 3 pipes/day)
• Inability to refrain from smoking on trial days
• Alcohol abuse (more than 60 g/day)
• Drug abuse
• Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
• Excessive physical activities (within one week prior to administration or during the trial)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Telmisartan

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

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: May 1, 2004
• Primary Completion: July 1, 2004
• Last Updated: October 13, 2014

Record last verified: 2014-10