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Trial record 40 of 71 for:    TELMISARTAN AND HYDROCHLOROTHIAZIDE

Safety, Tolerability and Pharmacokinetics of Single Rising and Multiple Oral Doses of Telmisartan / Hydrochlorothiazide (HCTZ) in Healthy Male Volunteers

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ClinicalTrials.gov Identifier: NCT02262780
Recruitment Status : Completed
First Posted : October 13, 2014
Last Update Posted : October 13, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:

Group 1:

To investigate safety, tolerability and pharmacokinetics of Telmisartan + HCTZ (T40/H12.5 and T80/H12.5)

Group 2:

To investigate safety, tolerability and pharmacokinetics of Telmisartan + HCTZ (T80/H12.5 x 7 days)


Condition or disease Intervention/treatment Phase
Healthy Drug: Low dose of telmisartan Drug: High dose of telmisartan Drug: HCTZ Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses (40 mg Telmisartan / 12.5 mg HCTZ to 80 mg Telmisartan / 12.5 mg HCTZ) and Multiple Oral Doses (80 mg Telmisartan / 12.5 mg HCTZ) of Drug in Healthy Male Volunteers
Study Start Date : December 2003
Actual Primary Completion Date : February 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Telmisartan

Arm Intervention/treatment
Experimental: Single low dose Telmisartan with HCTZ Drug: Low dose of telmisartan
Drug: HCTZ
Experimental: Single high dose Telmisartan with HCTZ Drug: High dose of telmisartan
Drug: HCTZ
Experimental: Multiple high dose Telmisartan with HCTZ Drug: High dose of telmisartan
Drug: HCTZ



Primary Outcome Measures :
  1. Number of patients with clinically relevant findings in physical examination [ Time Frame: up to 10 days after last drug administration ]
  2. Number of patients with clinically relevant findings in vital signs [ Time Frame: up to 10 days after last drug administration ]
    blood pressure, pulse rate, body temperature

  3. Number of patients with clinically relevant findings in 12-lead ECG [ Time Frame: up to 10 days after last drug administration ]
  4. Number of patients with clinically relevant findings in clinical laboratory tests [ Time Frame: up to 10 days after last drug administration ]
  5. Number of patients with adverse events [ Time Frame: up to 10 days after last drug administration ]
  6. Global assessment of tolerability by the investigator [ Time Frame: up to 10 days after last drug administration ]
    verbal rating scale


Secondary Outcome Measures :
  1. Maximum concentration of the analytes in plasma (Cmax) [ Time Frame: Up to 96 hours after drug administration ]
  2. Area under the concentration time curve of the analytes in plasma (AUC) [ Time Frame: Up to 96 hours after drug administration ]
  3. Time from dosing to maximum concentration of the analytes in plasma (tmax) [ Time Frame: Up to 96 hours after drug administration ]
  4. Terminal rate constant of the analytes in plasma (λz) [ Time Frame: Up to 96 hours after drug administration ]
  5. Terminal half-life of the analytes in plasma (t1/2) [ Time Frame: Up to 96 hours after drug administration ]
  6. Mean residence time of the analytes in the body after po administration (MRTpo) [ Time Frame: Up to 96 hours after drug administration ]
  7. Apparent clearance of the analytes in the plasma after extravascular administration (CL/F) [ Time Frame: Up to 96 hours after drug administration ]
  8. Apparent volume of distribution of the analytes in plasma during the terminal phase λz following an extravascular dose (Vz/F) [ Time Frame: Up to 96 hours after drug administration ]
  9. Amount of HCTZ that is eliminated in urine from the time interval t1 to t2 (Aet1-t2) [ Time Frame: Up to 48 hours after drug administration ]
  10. Fraction of HCTZ excreted unchanged in urine from time point t1 to t2 (fet1-t2) [ Time Frame: Up to 48 hours after drug administration ]
  11. Renal clearance of HCTZ in plasma from the time point t1 until the time point t2 (CLR, t1-t2) [ Time Frame: Up to 48 hours after drug administration ]
  12. Minimum measured concentration of the analytes in plasma at steady state over a uniform dosing interval τ (Cmin,ss) [ Time Frame: Up to 96 hours after drug administration ]
  13. Average concentration of the analytes in plasma at steady state (Cavg) [ Time Frame: Up to 96 hours after drug administration ]
  14. Accumulation ratio of the analytes in plasma after multiple dose administration over a uniform dosing interval τ (RA) [ Time Frame: Up to 96 hours after drug administration ]


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

Inclusion Criteria:

  • Healthy males according to the following criteria: No finding deviating of clinical relevance and no evidence of a clinically relevant concomitant disease based upon a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR), body temperature), 12-lead ECG, clinical laboratory tests
  • Age ≥20 and Age ≤35 years
  • Body Mass Index (BMI) ≥17.6 and BMI ≤26.4 kg/m2
  • Signed and dated written informed consent prior to admission to the study in accordance with "Good Clinical Practice (GCP)"

Exclusion Criteria:

  • 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 laboratory value outside the reference range that is of clinical relevance
  • Positive result for hepatitis B surface (HBs) antigen, anti hepatitis C virus (HCV) antibodies, Syphilitic test or HIV test
  • Surgery of gastrointestinal tract (except appendectomy)
  • History of relevant orthostatic hypotension (mean standing SBP varies by ≥ 20 mmHg from mean supine systolic blood pressure (SBP) and/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 formulation; known hypersensitivity to any other angiotensin II receptor antagonist; known hypersensitivity to sulfonamides or sulphonamide-derived drugs (e.g. thiazides)
  • History of impaired glucose tolerance
  • History of hypokalemia
  • History of hyperuricemia
  • Salt restriction therapy
  • 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
  • Participation in another trial with an investigational drug within four months or 6 half-lives of the investigational drug, whichever is longer, prior to administration or during the trial
  • Smoker (more than 20 cigarettes /day)
  • Alcohol abuse
  • Drug abuse
  • Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
  • Excessive physical activities (within seven days prior to administration)
  • Intake of alcohol within two days prior to administration
  • Inability to comply with dietary regimen of study centre
  • Inability to comply with smoking cessation during hospitalization

Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02262780     History of Changes
Other Study ID Numbers: 502.453
First Posted: October 13, 2014    Key Record Dates
Last Update Posted: October 13, 2014
Last Verified: October 2014
Additional relevant MeSH terms:
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Telmisartan
Hydrochlorothiazide
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators