Influence of Food on the Bioavailability of Two Doses of Telmisartan/HCTZ Fixed-dose Combination in Japanese Healthy Male Volunteers

• ClinicalTrials.gov Identifier: NCT02276378
• Recruitment Status: Completed
• First Posted: October 28, 2014
• Last Update Posted: October 28, 2014
• Sponsor: Boehringer Ingelheim
• Information provided by (Responsible Party): Boehringer Ingelheim

Study Description

Brief Summary:

To investigate the relative bioavailability and pharmacokinetics of the fixed-dose combination tablets (telmisartan 40 mg/HCTZ 12.5 mg and telmisartan 80 mg/HCTZ 12.5 mg) after food intake in comparison with those in the fasting state in healthy Japanese male volunteers

Condition or disease	Intervention/treatment	Phase
Healthy	Drug: Telmisartan low; Drug: Telmisartan high; Drug: Hydrochlorothiazide (HCTZ); Other: Japanese meal	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Influence of Food on the Bioavailability of Telmisartan 40 mg/HCTZ 12.5 mg Fixed-dose Combination and of Telmisartan 80 mg/HCTZ 12.5 mg Fixed-dose Combination in Japanese Healthy Male Volunteers (an Open-label, Randomised, Single-dose, Two-way Crossover Study)
• Study Start Date: July 2008
• Actual Primary Completion Date: August 2008

Arms and Interventions

Arm	Intervention/treatment
Experimental: Telmisartan low / HCTZ fixed-dose combination, fed	Drug: Telmisartan low; Drug: Hydrochlorothiazide (HCTZ); Other: Japanese meal
Experimental: Telmisartan high / HCTZ fixed-dose combination, fed	Drug: Telmisartan high; Drug: Hydrochlorothiazide (HCTZ); Other: Japanese meal
Active Comparator: Telmisartan low /HCTZ fixed-dose combination, fasted	Drug: Telmisartan low; Drug: Hydrochlorothiazide (HCTZ)
Active Comparator: Telmisartan high /HCTZ fixed-dose combination, fasted	Drug: Telmisartan high; Drug: Hydrochlorothiazide (HCTZ)

Outcome Measures

Primary Outcome Measures :

1. Area under the concentration-time curve of the analyte in the plasma over the time interval from 0 to the time of the last quantifiable data point (AUC0-tz) [ Time Frame: Up to 72 hours after drug administration ]
2. The maximum measured concentration of the analyte in the plasma (Cmax) [ Time Frame: Up to 72 hours after drug administration ]

Secondary Outcome Measures :

1. Area under the concentration-time curve of the analyte in the plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) [ Time Frame: Up to 72 hours after drug administration ]
2. Time from dosing to the maximum concentration of the analyte in the plasma (tmax) [ Time Frame: Up to 72 hours after drug administration ]
3. Terminal rate constant in the plasma (λz) [ Time Frame: Up to 72 hours after drug administration ]
4. Terminal half-life of the analyte in the plasma (t1/2) [ Time Frame: Up to 72 hours after drug administration ]
5. Mean residence time of the analyte in the body after oral administration (MRTpo) [ Time Frame: Up to 72 hours after drug administration ]
6. Number of participants with abnormal findings in physical examination [ Time Frame: Up to 72 hours after drug administration ]
7. Number of participants with clinically significant findings in vital signs [ Time Frame: Up to 72 hours after last drug administration ]
8. Number of participants with clinically significant findings in 12-lead ECG [ Time Frame: Up to 72 hours after drug administration ]
9. Number of participants with clinically significant findings in clinical laboratory parameters [ Time Frame: Up to 72 hours after drug administration ]
10. Number of participants with adverse events [ Time Frame: Up to 7 days after drug administration ]

Eligibility Criteria

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

Criteria

Inclusion Criteria:

Healthy males according to the following criteria:

1. Based upon a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR), body temperature), 12-lead ECG (electrocardiogram), clinical laboratory tests
2. Age ≥20 and Age ≤35 years
3. Body weight ≥50 kg
4. BMI ≥18.0 and BMI ≤25.0 kg/m2 (Body Mass Index)
5. Signed and dated written informed consent prior to admission to the study in accordance with Good clinical practice (GCP) and the local legislation.

Exclusion Criteria:

1. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
2. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
3. Chronic or relevant acute infections
4. Any clinical relevant findings of the laboratory test deviating from normal
5. Positive result for either hepatitis B surface (HBs) antigen, anti Hepatitis C virus (HCV) antibodies, syphilitic test or human immunodeficiency virus (HIV) test
6. History of surgery of gastrointestinal tract (except appendectomy)
7. History of relevant orthostatic hypotension, fainting spells or blackouts
8. Known hypersensitivity to any component of the formulation (telmisartan and hydrochlorothiazide), or to any other angiotensin II receptor blocker (ARBs), any other thiazides, or thiazide derivatives (e.c. sulfonamide derivatives like a chlorthalidone)
9. 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
10. 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
11. Participation in another trial with an investigational drug within 4 months or 6 half-lives of the investigational drug prior to administration
12. Smoker (≥20 cigarettes/day)
13. Alcohol abuse (60 g or more ethanol/day: ex. 3 middle-sized bottles of beer, 3 gous (equivalent to 540 mL) of sake)
14. Drug abuse
15. Blood donation (more than 100 mL within 4 weeks prior to administration or during the trial)
16. Excessive physical activities (within 1 week prior to administration or during the trial)
17. Intake of alcohol within 2 days prior to administration
18. Inability to comply with dietary regimen of study centre
19. Inability to refrain from smoking on trial days
20. Subjects judged to be inappropriate by the investigator or the sub-investigator

Contacts and Locations

No Contacts or Locations Provided

More Information

Additional Information:

Related Info 

• Responsible Party: Boehringer Ingelheim
• ClinicalTrials.gov Identifier: NCT02276378
• Other Study ID Numbers: 502.569
• First Posted: October 28, 2014
• Last Update Posted: October 28, 2014
• Last Verified: October 2014

Additional relevant MeSH terms:

Hydrochlorothiazide; Telmisartan; Antihypertensive Agents; Diuretics; Natriuretic Agents; Physiological Effects of Drugs; Sodium Chloride Symporter Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists