Influence of Food on the Bioavailability of Telmisartan/Amlodipine Fixed Dose Combination in Healthy Japanese Male Volunteers

• ClinicalTrials.gov Identifier: NCT02261064
• Recruitment Status: Completed
• First Posted: October 10, 2014
• Last Update Posted: October 10, 2014
• Sponsor: Boehringer Ingelheim
• Information provided by (Responsible Party): Boehringer Ingelheim

Study Description

Brief Summary:

Study to investigate the relative bioavailability and pharmacokinetics of the fixed-dose combination tablets (telmisartan 40 mg/amlodipine 5 mg and telmisartan 80 mg/amlodipine 5 mg) in the fed condition compared with those of the same fixed-dose combination in the fasting condition in healthy Japanese male volunteers.

Condition or disease	Intervention/treatment	Phase
Healthy	Drug: Telmisartan/Amlodipine low dose; Drug: Telmisartan/Amlodipine high dose; Other: Japanese meal	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Influence of Food on the Bioavailability of Telmisartan 40 mg/Amlodipine 5 mg Fixed-dose Combination and of Telmisartan 80 mg/Amlodipine 5 mg Fixed-dose Combination in Healthy Japanese Male Volunteers (a Phase I, Open-label, Randomised, Single-dose, Two-way Crossover Trial)
• Study Start Date: December 2008
• Actual Primary Completion Date: February 2009

Arms and Interventions

Arm	Intervention/treatment
Experimental: Telmisartan/Amlodipine low dose, fed; Telmisartan low dose/Amlodipine fixed-dose combination	Drug: Telmisartan/Amlodipine low dose; Other: Japanese meal
Active Comparator: Telmisartan/Amlodipine low dose, fasted; Telmisartan low dose/Amlodipine fixed-dose combination	Drug: Telmisartan/Amlodipine low dose
Experimental: Telmisartan/Amlodipine high dose, fed; Telmisartan high dose/Amlodipine fixed-dose combination	Drug: Telmisartan/Amlodipine high dose; Other: Japanese meal
Active Comparator: Telmisartan/Amlodipine high dose, fasted; Telmisartan high dose/Amlodipine fixed-dose combination	Drug: Telmisartan/Amlodipine high dose

Outcome Measures

Primary Outcome Measures :

1. 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 (AUC0-tz) [ Time Frame: up to 144 hours after drug administration ]
2. Maximum measured concentration of the analyte in plasma (Cmax) [ Time Frame: up to 144 hours after drug administration ]

Secondary Outcome Measures :

1. Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) [ Time Frame: up to 144 hours after drug administration ]
2. Time from dosing to the maximum concentration of the analyte in plasma (tmax) [ Time Frame: up to 144 hours after drug administration ]
3. Terminal rate constant of the analyte in plasma (λz) [ Time Frame: up to 144 hours after drug administration ]
4. Terminal half-life of the analyte in plasma (t1/2) [ Time Frame: up to 144 hours after drug administration ]
5. Mean residence time of the analyte in the body after po administration (MRTpo) [ Time Frame: up to 144 hours after drug administration ]
6. Number of subjects with adverse events [ Time Frame: up to 56 days ]

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 35 Years (Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

1. Healthy male volunteers without any clinically significant findings and complications on the basis of a complete medical history, including the physical examination, vital signs (blood pressure, pulse rate, body temperature), 12-lead electrocardiograms (ECGs), clinical laboratory tests
2. Age: ≥20 and Age ≤35 years
3. Body weight: ≥50 kg
4. Body mass index (BMI): ≥18.0 and ≤25.0 kg/m2
5. Signed and dated written informed consent prior to admission to the trial in accordance with the Good Clinical Practice (GCP) and the local legislation

Exclusion Criteria:

1. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, or hormonal disorders
2. Diseases of the central nervous system (such as epilepsy) or psychiatric or neurological disorders
3. Chronic or relevant acute infections
4. Any clinical relevant findings in laboratory test results deviating from normal
5. A positive result in hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies, a syphilitic test, or an human immunodeficiency virus (HIV) test
6. History of surgery of the gastrointestinal tract (except appendectomy)
7. History of relevant orthostatic hypotension, fainting spells, or blackouts
8. Known hypersensitivity to any component of the formulation (telmisartan and amlodipine), to any other angiotensin II receptor blockers, or to any other dihydropyridine compound
9. Intake of drugs with a long half-life (≥24 hours) within at least 1 month or less than 10 half-lives of the respective drug before drug administration
10. Intake of drugs which might reasonably influence the results of the trial on the basis of the knowledge at the time of protocol preparation within 7 days before drug administration
11. Participation in another trial with an investigational drug within 4 months or 6 half-lives of the investigational products before drug administration
12. Smoker (≥20 cigarettes/day)
13. Alcohol abuse (60 g or more ethanol/day: e.g., 3 middle-sized bottles of beer, 3 gous [equivalent to 540 mL] of sake)
14. Drug abuse
15. Blood donation (more than 100 mL within 4 weeks before drug administration)
16. Excessive physical activities (within 1 week before drug administration)
17. Intake of alcohol within 2 days before drug administration
18. Inability to comply with dietary regimen of the study centre
19. Inability to refrain from smoking during trial days
20. Subjects judged to be inappropriate by the investigator or a sub-investigator

Contacts and Locations

No Contacts or Locations Provided

More Information

Additional Information:

Related Info 

• Responsible Party: Boehringer Ingelheim
• ClinicalTrials.gov Identifier: NCT02261064
• Other Study ID Numbers: 1235.27
• First Posted: October 10, 2014
• Last Update Posted: October 10, 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