Steady State Pharmacokinetics of Telmisartan, Ramipril or the Combination Following Repeated Oral Doses to Healthy Male and Female Volunteers

NCT02215005 | Completed Phase 1

• 1 other identifier: 1236.6
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

Brief Summary

The main objective was to investigate the effect of concurrent dosing of 10 mg ramipril and 80 mg telmisartan on the multiple-dose pharmacokinetics of telmisartan and ramipril. Therefore the relative bioavailability of telmisartan and ramipril given in combination was determined in comparison with either telmisartan or ramipril given alone.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

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

  up to 72 hours after last drug administration of each treatment

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

  up to 72 hours after last drug administration of each treatment

Secondary Outcomes (18)

• Concentration of the analytes in plasma

  2, 4, and 12 hours after administration of the first dose of each treatment on day 1

• pre-dose concentration of the analytes in plasma immediately before the administration of the next dose

  pre-dose up to day 5 of each treatment

• tmax,ss (time from last dosing to the maximum concentration of the analytes in plasma at steady state)

  up to 72 hours after last drug administration of each treatment

• Cmin,ss (minimum concentration of the analytes in plasma at steady state over a uniform dosing interval τ)

  up to 72 hours after last drug administration of each treatment

• Cpre,ss (pre-dose concentration of the analytes in plasma immediately before the administration of the next dose at steady state)

  pre-dose up to day 5 of each treatment

Study Arms (3)

Telmisartan + Ramipril

EXPERIMENTAL

5 days qd

Drug: Telmisartan; Drug: Ramipril

Telmisartan

ACTIVE COMPARATOR

5 days qd

Drug: Telmisartan

Ramipril

ACTIVE COMPARATOR

5 days qd

Drug: Ramipril

Interventions

Telmisartan DRUG

Also known as: Micardis®

Telmisartan; Telmisartan + Ramipril

Ramipril DRUG

Also known as: Delix®

Ramipril; Telmisartan + Ramipril

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 ≤55 years
• Body mass index (BMI) ≥18.5 and ≤29.9 kg/m2
• 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 drugs that prolong the QT/QTc interval based on the knowledge at the time of protocol preparation within 10 days prior to administration of trial drug 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)
• 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
• Drug abuse
• Blood donation (more than 100 mL within four weeks prior to administration of trial drug or during the trial)

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: June 1, 2007
• Primary Completion: September 1, 2007
• Last Updated: August 13, 2014

Record last verified: 2014-08