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

NCT02261064 | Completed Phase 1

• 1 other identifier: 1235.27
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• 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

Study Arms (4)

Telmisartan/Amlodipine low dose, fed

EXPERIMENTAL

Telmisartan low dose/Amlodipine fixed-dose combination

Drug: Telmisartan/Amlodipine low dose; Other: Japanese meal

Telmisartan/Amlodipine low dose, fasted

ACTIVE COMPARATOR

Telmisartan low dose/Amlodipine fixed-dose combination

Drug: Telmisartan/Amlodipine low dose

Telmisartan/Amlodipine high dose, fed

EXPERIMENTAL

Telmisartan high dose/Amlodipine fixed-dose combination

Drug: Telmisartan/Amlodipine high dose; Other: Japanese meal

Telmisartan/Amlodipine high dose, fasted

ACTIVE COMPARATOR

Telmisartan high dose/Amlodipine fixed-dose combination

Drug: Telmisartan/Amlodipine high dose

Interventions

Telmisartan/Amlodipine low dose DRUG

Telmisartan/Amlodipine low dose, fasted; Telmisartan/Amlodipine low dose, fed

Telmisartan/Amlodipine high dose DRUG

Telmisartan/Amlodipine high dose, fasted; Telmisartan/Amlodipine high dose, fed

Japanese meal OTHER

Telmisartan/Amlodipine high dose, fed; Telmisartan/Amlodipine low dose, fed

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• Age: ≥20 and Age ≤35 years
• Body weight: ≥50 kg
• Body mass index (BMI): ≥18.0 and ≤25.0 kg/m2
• Signed and dated written informed consent prior to admission to the trial in accordance with the Good Clinical Practice (GCP) and the local legislation

You may not qualify if:

• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, or hormonal disorders
• Diseases of the central nervous system (such as epilepsy) or psychiatric or neurological disorders
• Chronic or relevant acute infections
• Any clinical relevant findings in laboratory test results deviating from normal
• 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
• History of surgery of the gastrointestinal tract (except appendectomy)
• History of relevant orthostatic hypotension, fainting spells, or blackouts
• Known hypersensitivity to any component of the formulation (telmisartan and amlodipine), to any other angiotensin II receptor blockers, or to any other dihydropyridine compound
• 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
• 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
• Participation in another trial with an investigational drug within 4 months or 6 half-lives of the investigational products before drug administration
• Smoker (≥20 cigarettes/day)
• Alcohol abuse (60 g or more ethanol/day: e.g., 3 middle-sized bottles of beer, 3 gous \[equivalent to 540 mL\] of sake)
• Drug abuse
• Blood donation (more than 100 mL within 4 weeks before drug administration)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Telmisartan; Amlodipine

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; Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring

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: October 9, 2014
• First Posted: October 10, 2014
• Study Start: December 1, 2008
• Primary Completion: February 1, 2009
• Last Updated: October 10, 2014

Record last verified: 2014-10