Pharmacokinetics of Telmisartan Alone and in Combination With Amlodipine in Healthy Volunteers

NCT02259816 | Completed Phase 1

• 1 other identifier: 1235.2
• Study Type: interventional
• Target: 38
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study to investigate the steady state pharmacokinetics of 80 mg telmisartan alone and in combination with repeated doses of 10 mg amlodipine

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Area under the concentration-time curve of telmisartan in plasma at steady state over a uniform dosing interval τ (AUCτ,ss)

  up to 15 days after first administration of study drug

• Maximum measured concentration of telmisartan in plasma at steady state over a uniform dosing interval τ (Cmax,ss)

  up to 15 days after first administration of study drug

Secondary Outcomes (17)

• AUCτ,ss for amlodipine

  up to 15 days after first administration of study drug

• Cmax,ss for amlodipine

  up to 15 days after first administration of study drug

• Maximum measured concentration of the analyte in plasma (Cmax)

  up to 12 hours after first administration of study drug

• Time from dosing to maximum measured concentration on plasma (tmax)

  up to 12 hours after first administration of study drug

• Area under the plasma concentration-time curve over a uniform dosing interval τ after administration of the first dose; corresponds to AUC0-24h (AUCτ,1)

  up to 12 hours after first administration of study drug

Study Arms (2)

Telmisartan

ACTIVE COMPARATOR

Drug: Telmisartan

Telmisartan and amlodipine

EXPERIMENTAL

Drug: Telmisartan; Drug: Amlodipine

Interventions

Telmisartan DRUG

Also known as: Micardis®

Telmisartan; Telmisartan and amlodipine

Amlodipine DRUG

Also known as: Norvasc®

Telmisartan and amlodipine

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males and females according to the following criteria:
• Based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests
• Age ≥18 and Age ≤50 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 and the local legislation

You may not qualify if:

• Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
• Any evidence of a clinically relevant concomitant disease
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Surgery of the 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 relevant allergy/hypersensitivity (including allergy to drug or its excipients)
• 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 or that prolong the QT/corrected QT interval 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 (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day)
• Inability to refrain from smoking on trial days
• Alcohol abuse (more than 60 g/day)
• Drug abuse

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Telmisartan; Amlodipine

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; Dihydropyridines; 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 6, 2014
• First Posted: October 9, 2014
• Study Start: May 1, 2006
• Primary Completion: August 1, 2006
• Last Updated: October 9, 2014

Record last verified: 2014-10