Influence of Food on the Bioavailability of Telmisartan / Ramipril Fixed Dose Combination in Healthy Male and Female Volunteers

NCT02214966 | Completed Phase 1

• 1 other identifier: 1236.3
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective was to investigate the relative bioavailability of the fixed dose combination (FDC) tablet (80 mg telmisartan / 10 mg ramipril) after food intake in comparison to the bioavailability of the FDC tablet while fasting.

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

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

  up to 96 hours after drug administration

• AUC0-24 (area under the concentration-time curve of the analytes in plasma over one dosing interval from 0 to 24h)

  up to 96 hours after drug administration

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

  up to 96 hours after drug administration

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

  up to 96 hours after drug administration

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

  up to 96 hours after drug administration

Secondary Outcomes (11)

• λz (terminal rate constant in plasma)

  up to 96 hours after drug administration

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

  up to 96 hours after drug administration

• MRTpo (mean residence time of the analytes in the body after po administration)

  up to 96 hours after drug administration

• CL/F (apparent clearance of the analytes in the plasma after extravascular administration)

  up to 96 hours after drug administration

• Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)

  up to 96 hours after drug administration

Study Arms (2)

Telmisartan/Ramipril, fed

EXPERIMENTAL

Drug: Telmisartan/Ramipril, fixed dose combination tablet; Other: high fat, high caloric meal

Telmisartan/Ramipril, fasted

ACTIVE COMPARATOR

Drug: Telmisartan/Ramipril, fixed dose combination tablet

Interventions

Telmisartan/Ramipril, fixed dose combination tablet DRUG

Telmisartan/Ramipril, fasted; Telmisartan/Ramipril, fed

high fat, high caloric meal OTHER

Telmisartan/Ramipril, fed

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 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
• 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: October 1, 2007
• Primary Completion: December 1, 2007
• Last Updated: August 13, 2014

Record last verified: 2014-08