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

Bioequivalence of the 80 mg Telmisartan Film-coated Tablet Compared With Two Tablets of the Conventional 40 mg Telmisartan Tablet Following Oral Administration in Healthy Male Volunteers (an Open-label, Randomised, Single-dose, Two-sequence, Four-period Replicated Crossover Study)

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Telmisartan film-coated tablet; Drug: Telmisartan uncoated tablet

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. 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

   • 1.1 No findings deviating from normal and of clinical relevance
   • 1.2 No evidence of a clinically relevant concomitant disease
2. Age ≥20 and ≤35 years
3. Body weight≥50kg
4. Body Mass Index ≥18.0 and ≤25.0 kg/m2
5. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation

Exclusion Criteria:

1. Any finding of the medical examination (including blood pressure, pulse rate, body temperature, and ECG) deviating from normal and of clinical relevance
2. Any evidence of a clinically relevant concomitant disease
3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, or hormonal disorders
4. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
5. Chronic or relevant acute infections
6. History of relevant allergy/hypersensitivity (including allergy to a drug or its excipients)
7. Any clinical relevant findings of the laboratory test deviating from normal
8. Positive result for either hepatitis B antigen, anti hepatitis C virus antibodies, syphilitic test or human immunodeficiency virus (HIV) test
9. History of surgery of gastrointestinal tract (except appendectomy)
10. 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
11. History of hepatic dysfunction (e.g. biliary cirrhosis, cholestasis)
12. History of serious renal dysfunction
13. History of bilateral renal artery stenosis or renal artery stenosis in a solitary kidney
14. History of cerebrovascular disorder
15. History of hyperkalemia
16. Known hypersensitivity to any component of the telmisartan formulation, or to any other angiotensin II receptor blockers
17. 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 of the investigational product
18. Use of any drugs within 10 days before administration of the investigational product or during the trial
19. Participation in another trial with an investigational drug within four months before administration of the investigational product or during the trial
20. Smoker (>10 cigarettes or >3 cigars or >3 pipes/day)
21. Alcohol abuse
22. Drug abuse
23. Blood donation (100 mL or more) within four weeks before administration of the investigational product
24. Excessive physical activities within one week before administration of the investigational product or during the trial
25. Intake of alcohol within 2 days prior to administration
26. Inability to comply with dietary regimen of study centre
27. Inability to refrain from smoking on trial days
28. Any other clinical conditions that investigator or sub-investigator judges that the subject is ineligible for study participation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Telmisartan, film-coated tablet; one tablet of telmisartan	Drug: Telmisartan film-coated tablet
Active Comparator: Telmisartan, conventional tablet; Two tablets of telmisartan	Drug: Telmisartan uncoated tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Number of subjects with adverse events	up to 72 hours after last drug administration
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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: October 9, 2014
• First Submitted That Met QC Criteria: October 9, 2014
• First Posted (Estimate): October 10, 2014

Study Record Updates

• Last Update Posted (Estimate): October 10, 2014
• Last Update Submitted That Met QC Criteria: October 9, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Telmisartan
• Other Study ID Numbers: 502.557