Bioequivalence of Telmisartan/Amlodipine Fixed Dose Combination Compared With Its Monocomponents in Healthy Male and Female Volunteers

NCT02193308 | Completed Phase 1

• 1 other identifier: 1235.4
• Study Type: interventional
• Target: 84
• Locations: 0 countries
• Sites: N/A

Brief Summary

To demonstrate the bioequivalence of 80 mg telmisartan / 10 mg amlodipine fixed dose combination (FDC) vs. its monocomponents

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 168 hours after drug administration

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

  up to 168 hours after drug administration

Secondary Outcomes (9)

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

  up to 168 hours after drug administration

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

  up to 168 hours after drug administration

• λz (terminal rate constant in plasma)

  up to 168 hours after drug administration

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

  up to 168 hours after drug administration

• MRTpo (mean residence time of the analyte in the body after oral administration)

  up to 168 hours after drug administration

Study Arms (2)

Telmisartan/Amlodipine FDC

EXPERIMENTAL

Drug: Telmisartan/Amlodipine FDC

Telmisartan + Amlodipine mono

ACTIVE COMPARATOR

Drug: Telmisartan; Drug: Amlodipine

Interventions

Telmisartan/Amlodipine FDC DRUG

Telmisartan/Amlodipine FDC

Telmisartan DRUG

Telmisartan + Amlodipine mono

Amlodipine DRUG

Telmisartan + Amlodipine mono

Eligibility Criteria

• Age: 18 Years - 55 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 ≤55 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 (especially unspecific inducing agents like St.John´s wort (Hypericum perforatum) or inhibitors like cimetidine) or that prolong the QT/QTc 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 during 24 hours prior to dosing and during the trial
• Alcohol abuse or inability to stop alcoholic beverages for 24 hours prior to dosing and during the trial
• 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: July 16, 2014
• First Posted: July 17, 2014
• Study Start: September 1, 2007
• Primary Completion: November 1, 2007
• Last Updated: July 18, 2014

Record last verified: 2014-07