Bioavailability of Telmisartan/Amlodipine Fixed-dose Combination Compared to Its Mono-components in Healthy Male Volunteers

NCT02259790 | Completed Phase 1

• 1 other identifier: 1235.17
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study to investigate the relative bioavailability of fixed-dose combination tablet vs. mono-components of telmisartan and amlodipine

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

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

  up to 144 hours after administration of study drug

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

  up to 144 hours after administration of study drug

Secondary Outcomes (9)

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

  up to 144 hours after administration of study drug

• Time from administration to the maximum concentration of the analyte in plasma (tmax)

  up to 144 hours after administration of study drug

• Terminal rate constant of the analyte in plasma (λz)

  up to 144 hours after administration of study drug

• Terminal half-life of the analyte in plasma (t1/2)

  up to 144 hours after administration of study drug

• Mean residence time of the analyte in the body after po administration (MRTpo)

  up to 144 hours after administration of study drug

Study Arms (2)

Telmisartan/amlodipine fixed-dose combination

EXPERIMENTAL

Drug: Telmisartan/amlodipine fixed-dose combination tablet

Telmisartan tablet and amlodipine tablet

ACTIVE COMPARATOR

Drug: Telmisartan; Drug: Amlodipine

Interventions

Telmisartan/amlodipine fixed-dose combination tablet DRUG

Telmisartan/amlodipine fixed-dose combination

Telmisartan DRUG

Telmisartan tablet and amlodipine tablet

Amlodipine DRUG

Telmisartan tablet and amlodipine tablet

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: male
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males according to the following criteria:
• Based upon a complete medical history, including the physical examination, vital signs (blood pressure, pulse rate and body temperature), 12-lead ECG, clinical laboratory tests, no finding of clinical relevance, no evidence of a clinically relevant concomitant disease
• Age ≥20 and Age ≤35 years
• Body weight ≥50 kg
• BMI ≥17.6 and BMI ≤26.4 kg/m2 (Body Mass Index)
• Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice

You may not qualify if:

• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
• Chronic or relevant acute infections
• Any clinical relevant findings of the laboratory test deviating from normal
• Positive result for hepatitis B antigen, anti hepatitis C virus anti bodies, syphilitic test or HIV test
• Surgery of gastrointestinal tract (except appendectomy)
• History of relevant orthostatic hypotension (mean standing systolic blood pressure (SBP) varies by ≥20 mmHg from mean supine SBP or mean standing diastolic blood pressure (DBP) varies by ≥10 mmHg from mean supine DBP), fainting spells or blackouts
• History of hepatic dysfunction (e.g. biliary cirrhosis, cholestasis)
• History of serious renal dysfunction
• History of bilateral renal artery stenosis or renal artery stenosis in a solitary kidney
• History of cerebrovascular disorder
• History of hyperkalemia
• Known hypersensitivity to any component of the formulation, or to any other angiotensin II receptor antagonists, angiotensin converting enzyme or dihydropyridine
• 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 7 days prior to administration or during the trial

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: July 1, 2007
• Primary Completion: August 1, 2007
• Last Updated: October 9, 2014

Record last verified: 2014-10