Bioequivalence of Telmisartan/g Ramipril Fixed Dose Combination Compared With the Monocomponents Telmisartan and Ramipril (Two Different Formulations) Given Concomitantly to Healthy Male and Female Volunteers

NCT02214992 | Completed Phase 1

• 1 other identifier: 1236.5
• Study Type: interventional
• Target: 84
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study to demonstrate the bioequivalence of 80 mg telmisartan/10 mg ramipril fixed dose combination versus its monocomponents given concurrently

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 96 hours after drug administration

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

  up to 96 hours after drug administration

Secondary Outcomes (13)

• 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 96 hours after drug administration

• AUCt1-t2 (area under the concentration-time curve of the analyte in plasma over the time interval from t1 to t2)

  up to 96 hours after drug administration

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

  up to 96 hours after drug administration

• λz (terminal rate constant in plasma)

  up to 96 hours after drug administration

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

  up to 96 hours after drug administration

Study Arms (3)

Telmisartan/Ramipril

EXPERIMENTAL

Fixed dose combination tablet

Drug: Telmisartan/Ramipril

Telmisartan + Ramipril capsule

ACTIVE COMPARATOR

Drug: Telmisartan; Drug: Ramipril capsule

Telmisartan + Ramipril tablet

ACTIVE COMPARATOR

Drug: Telmisartan; Drug: Ramipril tablet

Interventions

Telmisartan/Ramipril DRUG

Fixed dose combination tablet

Telmisartan/Ramipril

Telmisartan DRUG

Also known as: Micardis®

Telmisartan + Ramipril capsule; Telmisartan + Ramipril tablet

Ramipril capsule DRUG

Also known as: Altace®

Telmisartan + Ramipril capsule

Ramipril tablet DRUG

Also known as: Delix®

Telmisartan + Ramipril tablet

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 (Blood Pressure (BP), Pulse Rate (PR)), 12-lead electrocardiogram (ECG), clinical laboratory tests
• Age ≥ 18 and Age ≤ 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 24 hours after dosing
• Alcohol abuse (more than 60 g/day) or inability to stop alcoholic beverages for 24 hours prior to dosing and up to the last sampling time point, 96 hours after dosing
• Drug abuse

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Telmisartan; Ramipril

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: August 12, 2014
• First Posted: August 13, 2014
• Study Start: March 1, 2007
• Primary Completion: June 1, 2007
• Last Updated: August 13, 2014

Record last verified: 2014-08