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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Telmisartan/Amlodipine low dose; Drug: Telmisartan/Amlodipine high dose; Other: Japanese meal

• Registration Number: NCT02261064
• Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Primary Completion: 2009-02
• Status Verified: 2014-10
• Study First Submitted: 2014-10-09
• Study First Submitted QC: 2014-10-09
• Last Update Submitted: 2014-10-09
• Study First Posted: 2014-10-10
• Last Update Posted: 2014-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 32

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Telmisartan/Amlodipine low dose, fed	Telmisartan/Amlodipine low dose	Telmisartan low dose/Amlodipine fixed-dose combination
Telmisartan/Amlodipine low dose, fed	Japanese meal	Telmisartan low dose/Amlodipine fixed-dose combination
Telmisartan/Amlodipine low dose, fasted	Telmisartan/Amlodipine low dose	Telmisartan low dose/Amlodipine fixed-dose combination
Telmisartan/Amlodipine high dose, fed	Telmisartan/Amlodipine high dose	Telmisartan high dose/Amlodipine fixed-dose combination
Telmisartan/Amlodipine high dose, fed	Japanese meal	Telmisartan high dose/Amlodipine fixed-dose combination
Telmisartan/Amlodipine high dose, fasted	Telmisartan/Amlodipine high dose	Telmisartan high dose/Amlodipine fixed-dose combination

Primary Outcome Measures

Name	Time	Method
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)	up to 144 hours after drug administration
Maximum measured concentration of the analyte in plasma (Cmax)	up to 144 hours after drug administration

Secondary Outcome Measures

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