Safety, Tolerability and Pharmacokinetics of Single and Multiple Oral Doses of 40 mg Telmisartan/5 mg Amlodipine and 80 mg Telmisartan/5 mg Amlodipine in Healthy Male Volunteers

NCT02194309 | Completed Phase 1

• 1 other identifier: 1235.9
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

To investigate safety, tolerability, and pharmacokinetics of telmisartan and amlodipine following single administration of 40 mg telmisartan/5 mg amlodipine and 80 mg telmisartan/5 mg amlodipine, and subsequently, following multiple administration of 40 mg telmisartan/5 mg amlodipine and 80 mg telmisartan/5 mg amlodipine once daily for 10 days

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

• Number of patients with clinically significant changes in vital signs (blood pressure, pulse rate, body temperature)

  up to 6 days after last administration in multiple dose phase

• Number of patients with clinically significant changes in 12-lead electrocardiogram (ECG)

  up to 6 days after last administration in multiple dose phase

• Number of patients with clinically significant changes in laboratory parameters

  up to 6 days after last administration in multiple dose phase

• Number of patients with adverse events

  up to 6 days after last administration in multiple dose phase

• Assessment of tolerability by investigator on a four-point scale

  up to 6 days after last administration in multiple dose phase

Secondary Outcomes (13)

• Cmax (maximum measured concentration of the analyte in plasma) for several time points

  up to day 16

• tmax (time from dosing to the maximum measured concentration of the analyte in plasma) for several time points

  up to day 16

• Cmin,ss (minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ)

  up to day 16

• AUC (area under the concentration-time curve of the analyte in plasma) for several time points

  up to day 16

• λz (terminal rate constant in plasma) for several time points

  up to day 16

Study Arms (2)

Telmisartan low + amlodipine

EXPERIMENTAL

Drug: Telmisartan low; Drug: amlodipine

Telmisartan high + amlodipine

EXPERIMENTAL

Drug: Telmisartan high; Drug: amlodipine

Interventions

Telmisartan low DRUG

Telmisartan low + amlodipine

Telmisartan high DRUG

Telmisartan high + amlodipine

amlodipine DRUG

Telmisartan high + amlodipine; Telmisartan low + amlodipine

Eligibility Criteria

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

You may qualify if:

• Healthy male volunteers according to the following criteria:
• No finding deviating of clinical relevance and no evidence of a clinically relevant concomitant disease based upon a complete medical history, including the physical examination, vital signs (blood pressure, pulse rate, body temperature), 12-lead ECG, clinical laboratory tests
• Age ≥20 and Age ≤35 years
• Body weight ≥50 kg
• Body mass index (BMI) ≥17.6 and BMI ≤26.4 kg/m2
• Signed and dated written informed consent before admission to the trial

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 disorders or neurological disorders
• Chronic or relevant acute infections
• Any clinical relevant findings of the laboratory test deviating from normal
• Positive result for either hepatitis B surface antigen (HBsAg), anti hepatitis C virus (HCV) antibodies, syphilitic test or human immunodeficiency virus (HIV) test
• History of surgery of gastrointestinal tract (except appendectomy)
• History of relevant orthostatic hypotension (mean standing systolic blood pressure (SBP) varied by ≥20 mmHg from mean supine SBP or mean standing diastolic blood pressure (DBP) varied by ≥10 mmHg from mean supine DBP), fainting spells or blackouts
• History of hepatic dysfunction (e.g., biliary cirrhosis, cholestasis)
• History of serious renal dysfunction
• History of bilateral renal artery stenosis or renal artery stenosis in a solitary kidney
• History of cerebrovascular disorder
• History of hyperkalemia
• Known hypersensitivity to any component of the formulation, or to any other Angiotensin Receptor Blocker (ARB), angiotensin converting enzyme or dihydropyridine
• 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 before administration or during the trial
• Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 7 days before administration or during the trial

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Amlodipine

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2014
• First Posted: July 18, 2014
• Study Start: September 1, 2006
• Primary Completion: December 1, 2006
• Last Updated: July 18, 2014

Record last verified: 2014-07