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

NCT02262780 | Completed Phase 1

• 1 other identifier: 502.453
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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)

Conditions

Healthy

Outcome Measures

Primary Outcomes (6)

• Number of patients with clinically relevant findings in physical examination

  up to 10 days after last drug administration

• Number of patients with clinically relevant findings in vital signs

  blood pressure, pulse rate, body temperature

  up to 10 days after last drug administration

• Number of patients with clinically relevant findings in 12-lead ECG

  up to 10 days after last drug administration

• Number of patients with clinically relevant findings in clinical laboratory tests

  up to 10 days after last drug administration

• Number of patients with adverse events

  up to 10 days after last drug administration

• Global assessment of tolerability by the investigator

  verbal rating scale

  up to 10 days after last drug administration

Secondary Outcomes (14)

• Maximum concentration of the analytes in plasma (Cmax)

  Up to 96 hours after drug administration

• Area under the concentration time curve of the analytes in plasma (AUC)

  Up to 96 hours after drug administration

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

  Up to 96 hours after drug administration

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

  Up to 96 hours after drug administration

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

  Up to 96 hours after drug administration

Study Arms (3)

Single low dose Telmisartan with HCTZ

EXPERIMENTAL

Drug: Low dose of telmisartan; Drug: HCTZ

Single high dose Telmisartan with HCTZ

EXPERIMENTAL

Drug: High dose of telmisartan; Drug: HCTZ

Multiple high dose Telmisartan with HCTZ

EXPERIMENTAL

Drug: High dose of telmisartan; Drug: HCTZ

Interventions

Low dose of telmisartan DRUG

Single low dose Telmisartan with HCTZ

High dose of telmisartan DRUG

Multiple high dose Telmisartan with HCTZ; Single high dose Telmisartan with HCTZ

HCTZ DRUG

Multiple high dose Telmisartan with HCTZ; Single high dose Telmisartan with HCTZ; Single low dose Telmisartan with HCTZ

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)"

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Telmisartan; Hydrochlorothiazide

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Thiazides

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2014
• First Posted: October 13, 2014
• Study Start: December 1, 2003
• Primary Completion: February 15, 2004
• Last Updated: December 8, 2023

Record last verified: 2023-11