Bioequivalence of Telmisartan Film-coated Tablet Compared With Two Tablets of the Conventional Telmisartan Tablet in Healthy Male Volunteers

NCT02261129 | Completed Phase 1

• 1 other identifier: 502.557
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study to demonstrate the bioequivalence of the telmisartan 80 mg film-coated tablet vs. two tablets of the telmisartan 40 mg conventional tablet

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 last quantifiable data point (AUC0-tz)

  up to 72 hours after drug administration

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

  up to 72 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 72 hours after drug administration

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

  up to 72 hours after drug administration

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

  up to 72 hours after drug administration

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

  up to 72 hours after drug administration

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

  up to 72 hours after drug administration

Study Arms (2)

Telmisartan, film-coated tablet

EXPERIMENTAL

one tablet of telmisartan

Drug: Telmisartan film-coated tablet

Telmisartan, conventional tablet

ACTIVE COMPARATOR

Two tablets of telmisartan

Drug: Telmisartan uncoated tablet

Interventions

Telmisartan film-coated tablet DRUG

Telmisartan, film-coated tablet

Telmisartan uncoated 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 Japanese 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 weight≥50kg
• Body Mass Index ≥18.0 and ≤25.0 kg/m2
• Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation

You may not qualify if:

• Any finding of the medical examination (including blood pressure, pulse rate, body temperature, and ECG) deviating from normal and of clinical relevance
• Any evidence of a clinically relevant concomitant disease
• 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
• History of relevant allergy/hypersensitivity (including allergy to a drug or its excipients)
• Any clinical relevant findings of the laboratory test deviating from normal
• Positive result for either hepatitis B antigen, anti hepatitis C virus 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

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: September 1, 2008
• Primary Completion: December 1, 2008
• Last Updated: October 10, 2014

Record last verified: 2014-10