Clinical trial NCT02262624: Bioequivalence of Telmisartan / HCTZ Fixed Dose Combination Compared to Its Monocomponents in Healthy Male Volunteers
Official title: Bioequivalence of 80 mg Telmisartan/12.5 mg HCTZ of Fixed Dose Combination Compared to Its Monocomponents in Healthy Male Volunteers (an Open-label, Randomised, Single-dose, Two-way Crossover Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-10-13
Enrollment: 36
Sex: MALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To establish the bioequivalence of 80 mg telmisartan/12.5 mg HCTZ fixed dose combination vs. its monocomponents


Eligibility criteria: Inclusion Criteria:

1. Healthy males according to the following criteria:

   Based upon a complete medical history, physical finding, physical examination (measurements of height and body weight), vital signs (blood pressure (BP), pulse rate (PR)), 12-lead ECG (electrocardiogram), clinical laboratory tests 1) No finding of clinical relevance 2) No evidence of a clinically relevant concomitant disease
2. Age ≥ 20 years and age ≤ 35 years
3. Body Mass Index (BMI) ≥ 17.6 kg/m2 and BMI ≤ 25.0 kg/m2
4. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) (MHW Ordinance No. 28, as of Mar. 27, 1997) and the local legislation

Exclusion Criteria:

1. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
2. Surgery of gastrointestinal tract (except appendectomy)
3. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
4. History of relevant orthostatic hypotension, fainting spells or blackouts
5. Chronic or relevant acute infections
6. History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
7. Positive result for Hepatitis B virus surface antigen (HBsAg), anti HCV (Hepatitis C virus), syphilitic test or Human immunodeficiency virus (HIV) antigen-antibody test
8. Intake of drugs with a long half-life (≥ 24 hours) within at least 1 month prior to administration or within a period of 10 or less half-lives of the respective drugs during the trial
9. Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial.
10. Participation in another trial with an investigational drug within 4 months prior to administration or during the trial
11. Smoker (20 or more cigarettes/day)
12. Inability to refrain from smoking during hospitalisation
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 four weeks prior to administration or during the trial)
16. Excessive physical activities (within one week prior to administration or during the trial)
17. Any laboratory value outside the reference range that is of clinical relevance
18. Inability to comply with dietary regimen of study centre
19. Any other volunteers whom, the investigator or sub investigator would not allow to participate in this study

Primary outcomes:
measure: AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)
timeFrame: Up to 72 hours after drug administration
measure: Cmax (maximum measured concentration of the analyte in plasma)
timeFrame: Up to 72 hours after drug administration
Secondary outcomes:
measure: AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
timeFrame: Up to 72 hours after drug administration
measure: tmax (time from dosing to the maximum concentration of the analyte in plasma)
timeFrame: Up to 72 hours after drug administration
measure: λz (terminal rate constant of the analyte in plasma)
timeFrame: Up to 72 hours after drug administration
measure: t1/2 (terminal half-life of the analyte in plasma)
timeFrame: Up to 72 hours after drug administration
measure: MRTpo (mean residence time of the analyte in the body after po administration)
timeFrame: Up to 72 hours after drug administration
measure: Number of participants with clinically significant findings in physical examination
timeFrame: Up to 9 days after last drug administration
measure: Number of participants with clinically significant findings in vital signs
timeFrame: Up to 9 days after last drug administration
measure: Number of participants with clinically significant findings in 12-lead ECG (electrocardiogram)
timeFrame: Up to 9 days after last drug administration
measure: Number of participants with clinically significant findings in laboratory parameters
timeFrame: Up to 9 days after last drug administration
measure: Number of participants with adverse events
timeFrame: Up to 9 days after last drug administration
Other outcomes:
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