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

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ClinicalTrials.gov Identifier: NCT02214966
Recruitment Status : Completed
First Posted : August 13, 2014
Last Update Posted : August 13, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Telmisartan/Ramipril, fixed dose combination tablet Other: high fat, high caloric meal Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Influence of Food on the Bioavailability of 80 mg Telmisartan / 10 mg Ramipril Fixed Dose Combination in Healthy Male and Female Volunteers (an Open-label, Randomised, Single-dose, Two-sequence, Two-period Crossover Study)
Study Start Date : October 2007
Actual Primary Completion Date : December 2007

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Telmisartan/Ramipril, fed Drug: Telmisartan/Ramipril, fixed dose combination tablet
Other: high fat, high caloric meal
Active Comparator: Telmisartan/Ramipril, fasted Drug: Telmisartan/Ramipril, fixed dose combination tablet



Primary Outcome Measures :
  1. AUC0-∞ (area under the concentration-time curve of the analytes in plasma over the time interval from 0 extrapolated to infinity) [ Time Frame: up to 96 hours after drug administration ]
  2. AUC0-24 (area under the concentration-time curve of the analytes in plasma over one dosing interval from 0 to 24h) [ Time Frame: up to 96 hours after drug administration ]
  3. Cmax (maximum measured concentration of the analytes in plasma) [ Time Frame: up to 96 hours after drug administration ]
  4. 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) [ Time Frame: up to 96 hours after drug administration ]
  5. tmax (time from dosing to the maximum concentration of the analytes in plasma) [ Time Frame: up to 96 hours after drug administration ]

Secondary Outcome Measures :
  1. λz (terminal rate constant in plasma) [ Time Frame: up to 96 hours after drug administration ]
  2. t1/2 (terminal half-life of the three analytes in plasma) [ Time Frame: up to 96 hours after drug administration ]
  3. MRTpo (mean residence time of the analytes in the body after po administration) [ Time Frame: up to 96 hours after drug administration ]
  4. CL/F (apparent clearance of the analytes in the plasma after extravascular administration) [ Time Frame: up to 96 hours after drug administration ]
  5. Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose) [ Time Frame: up to 96 hours after drug administration ]
  6. Number of patients with adverse events [ Time Frame: up to 54 days ]
  7. Assessment of tolerability by investigator on a 4-point scale [ Time Frame: Day 5 of each treatment period ]
  8. Number of patients with clinically significant changes in Vital Signs (Blood Pressure, Pulse Rate) [ Time Frame: up to 54 days ]
  9. Number of patients with clinically significant changes in laboratory tests [ Time Frame: up to 54 days ]
  10. Number of patients with clinically significant changes in Electrocardiogram (ECG) [ Time Frame: up to 54 days ]
  11. AUC0-tz (area under the concentration-time curve of ramiprilat and telmisartan in plasma over the time interval from 0 to the time of the last quantifiable data point) [ Time Frame: up to 96 hours after drug administration ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
  • Excessive physical activities (within one week prior to administration of trial drug or during the trial)
  • Any laboratory value outside the reference range that is of clinical relevance
  • Inability to comply with dietary regimen of trial site
  • A marked baseline prolongation of QT/QTc interval (e.g. repeated demonstration of a QTc interval >450 ms)
  • A history of additional risk factors for torsade de pointes (e.g., heart failure, hyperkalemia, hypokalemia, family history of Long QT Syndrome)
  • Any history of relevant low BP
  • Supine blood pressure at screening of systolic <110 mm Hg and diastolic <60 mm Hg
  • History of urticaria
  • History of angioneurotic edema
  • Hereditary fructose intolerance
  • Salt and/or volume depletion

For female subjects:

  • Pregnancy / positive pregnancy test, or planning to become pregnant during the study or within 1 month of study completion
  • No adequate contraception during the study and until 1 month of study completion, i.e. implants, injectables, combined oral contraceptives, intrauterine device, sexual abstinence (for at least 1 month prior to enrolment), vasectomised partner (vasectomy performed at least 1 year prior to enrolment) or surgical sterilisation (incl. hysterectomy). Females, who have not a vasectomised partner, are not sexually abstinent or surgically sterile will be asked to additionally use barrier contraception methods (e.g. condom, diaphragm with spermicide)
  • Currently lactating

Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02214966    
Other Study ID Numbers: 1236.3
First Posted: August 13, 2014    Key Record Dates
Last Update Posted: August 13, 2014
Last Verified: August 2014
Additional relevant MeSH terms:
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Telmisartan
Ramipril
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors