Bioequivalence of Telmisartan Film-coated Tablet Compared With the Conventional Telmisartan Tablet Following Oral Administration in Healthy Male Volunteers

NCT02263989 | Completed Phase 1

• 1 other identifier: 502.520
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study to investigate the bioequivalence of the 40 mg telmisartan film-coated tablet vs. the conventional 40 mg telmisartan tablet

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to last quantifiable data point)

  up to 72 hours after drug administration

• Cmax (maximum measured concentration of the analyte in plasma)

  up to 72 hours after drug administration

Secondary Outcomes (10)

• AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)

  up to 72 hours after drug administration

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

  up to 72 hours after drug administration

• λz (terminal rate constant of the analyte in plasma)

  up to 72 hours after drug administration

• t1/2 (terminal half-life of the analyte in plasma)

  up to 72 hours after drug administration

• MRTpo (mean residence time of the analyte in the body after po administration)

  up to 72 hours after drug administration

Study Arms (2)

Telmisartan film coated tablet

EXPERIMENTAL

Drug: Telmisartan film coated tablet

Telmisartan conventional tablet

ACTIVE COMPARATOR

Drug: Telmisartan conventional tablet

Interventions

Telmisartan film coated tablet DRUG

Telmisartan film coated tablet

Telmisartan conventional tablet DRUG

Telmisartan conventional tablet

Eligibility Criteria

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

You may qualify if:

• Healthy males according to the following criteria:
• Based upon a complete medical history, including the physical examination, vital signs (blood pressure, pulse rate, body temperature), 12-lead ECG, clinical laboratory tests
• No findings deviating from normal and of clinical relevance
• No evidence of a clinically relevant concomitant disease
• Age ≥20 and ≤35 years
• Body mass index (BMI) ≥17.6 and ≤26.4 kg/m2
• Signed and dated written informed consent prior to admission to the study in accordance with 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 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 (HBs antigen), 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) varies by ≥20 mmHg from mean supine SBP or mean standing diastolic blood pressure (DBP) varies 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 telmisartan formulation, or to any other angiotensin II receptor blockers (ARBs)
• 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
• 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 prior to administration or during the trial

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Telmisartan

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

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 13, 2014
• First Posted: October 15, 2014
• Study Start: January 1, 2007
• Primary Completion: April 1, 2007
• Last Updated: October 15, 2014

Record last verified: 2014-10