Bioavailability of Telmisartan/Amlodipine Fixed Dose Combination in Healthy Male and Female Volunteers

• ClinicalTrials.gov Identifier: NCT02259777
• Recruitment Status: Completed
• First Posted: October 9, 2014
• Last Update Posted: October 9, 2014
• Sponsor: Boehringer Ingelheim
• Information provided by (Responsible Party): Boehringer Ingelheim

Study Description

Brief Summary:

Study to investigate the effect of food intake on the bioavailability of a fixed dose combination of 80 mg telmisartan / 10 mg amlodipine following a high fat breakfast

Condition or disease	Intervention/treatment	Phase
Healthy	Drug: Telmisartan/Amlodipine; Other: high fat, high caloric meal	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 40 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 Amlodipine Fixed Dose Combination in Healthy Male and Female Volunteers. An Open-label, Randomised, Single-dose, Two Period, Crossover Study
• Study Start Date: September 2007
• Actual Primary Completion Date: November 2007

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Area under the concentration-time curve of the analyte in plasma over the time interval from zero extrapolated to infinity (AUC0-∞) [ Time Frame: up to 168 hours after drug administration ]
2. Maximum measured concentration of the analyte in plasma (Cmax) [ Time Frame: up to 168 hours after drug administration ]

Secondary Outcome Measures :

1. Area under the concentration-time curve of telmisartan and amlodipine in plasma over the time interval zero to the last quantifiable data point (AUC0-tz) [ Time Frame: up to 168 hours after drug administration ]
2. Time from dosing to the maximum concentration in plasma (tmax) [ Time Frame: up to 168 hours after drug administration ]
3. Terminal rate constant in plasma (λz) [ Time Frame: up to 168 hours after drug administration ]
4. Terminal half-life in plasma (t1/2) [ Time Frame: up to 168 hours after drug administration ]
5. Mean residence time in the body after po administration (MRTpo) [ Time Frame: up to 168 hours after drug administration ]
6. Apparent plasma clearance after p.o. administration (CL/F) [ Time Frame: up to 168 hours after drug administration ]
7. Apparent volume of distribution during the terminal phase λz after p.o. administration (Vz/F) [ Time Frame: up to 168 hours after drug administration ]
8. Number of subjects with adverse events [ Time Frame: up to 65 days ]
9. Assessment of tolerability by investigator on a 4-point scale [ Time Frame: day 8 after administration of study drug ]

Eligibility Criteria

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

Criteria

Inclusion Criteria:

1. 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

2. Age ≥18 and Age ≤55 years
3. BMI ≥18.5 and BMI ≤29.9 kg/m2 (Body Mass Index)
4. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation

Exclusion Criteria:

1. Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
2. Any evidence of a clinically relevant concomitant disease
3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
4. Surgery of the gastrointestinal tract (except appendectomy)
5. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
6. History of relevant orthostatic hypotension, fainting spells or blackouts
7. Chronic or relevant acute infections
8. History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
9. 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 except for oral contraceptives as well as ovary and thyroid hormone replacement
10. 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/corrected QT interval based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
11. Participation in another trial with an investigational drug within one month prior to administration or during the trial
12. Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
13. Inability to refrain from smoking during 24 hours prior to dosing and during the trial
14. Alcohol abuse or inability to stop alcoholic beverages for 24 hours prior to dosing and during the trial
15. Drug abuse
16. Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
17. Excessive physical activities (within one week prior to administration or during the trial)
18. Any laboratory value outside the reference range that is of clinical relevance
19. Inability to comply with dietary regimen of trial site
20. Any history of relevant low blood pressure
21. Supine blood pressure at screening of systolic <110 mm Hg and diastolic <60 mm Hg
22. History of urticaria
23. History of angioneurotic edema

24. Fructose intolerance

    For female subjects:

25. Pregnancy / positive pregnancy test, or planning to become pregnant during the study or within 1 month of study completion
26. No adequate contraception during the study and until 1 month of study completion, i.e. implants, injectables, combined oral contraceptives, IUD [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)
27. Lactation period

Contacts and Locations

No Contacts or Locations Provided

More Information

Additional Information:

Related Info 

• Responsible Party: Boehringer Ingelheim
• ClinicalTrials.gov Identifier: NCT02259777
• Other Study ID Numbers: 1235.12
• First Posted: October 9, 2014
• Last Update Posted: October 9, 2014
• Last Verified: October 2014

Additional relevant MeSH terms:

Amlodipine; Telmisartan; Telmisartan amlodipine combination; Antihypertensive Agents; Calcium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Vasodilator Agents; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists