Bioequivalence of Telmisartan/ HCTZ Fixed Dose Combination Compared With Its Monocomponents in Healthy Male Volunteers II

NCT02262858 | Completed Phase 1

• 1 other identifier: 502.495
• Study Type: interventional
• Target: 68
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study to investigate the bioequivalence of 80 mg telmisartan/12.5 mg hydrochlorothiazide (HCTZ) fixed dose combination compared with its monocomponents

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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)

  up to 72 hours after drug administration

• Cmax (maximum measured concentration of the analyte in plasma)

  up to 72 hours after drug administration

Secondary Outcomes (9)

• AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)

  up to 72 hours after drug administration

• tmax (time from dosing to the maximum concentration of the analyte in plasma)

  up to 72 hours after drug administration

• λz (terminal rate constant of the analyte in plasma)

  up to 72 hours after drug administration

• t1/2 (terminal half-life of the analyte in plasma)

  up to 72 hours after drug administration

• MRTpo (mean residence time of the analyte in the body after po administration)

  up to 72 hours after drug administration

Study Arms (2)

Telmisartan and HCTZ (fix dose combination)

EXPERIMENTAL

Drug: Telmisartan and HCTZ

Telmisartan and HCTZ (monocomponent)

ACTIVE COMPARATOR

Drug: Telmisartan; Drug: HCTZ

Interventions

Telmisartan and HCTZ DRUG

Telmisartan and HCTZ (fix dose combination)

Telmisartan DRUG

Telmisartan and HCTZ (monocomponent)

HCTZ DRUG

Telmisartan and HCTZ (monocomponent)

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:
• Based upon a complete medical history, physical finding, physical examination (measurements of height and body weight), vital signs (blood pressure, pulse rate), 12- lead ECG, clinical laboratory tests (including gastric acid (GA) test)
• No finding of clinical relevance
• No evidence of a clinically relevant concomitant disease
• Age ≥ 20 years and Age ≤ 35 years
• Body weight ≥ 50 kg
• Body mass index (BMI) ≥ 17.6 kg/m2 and BMI ≤ 25.0 kg/m2
• Signed and dated written informed consent prior to admission to the study

You may not qualify if:

• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Surgery of gastrointestinal tract (except appendectomy)
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
• History of relevant orthostatic hypotension, fainting spells or blackouts
• Chronic or relevant acute infections
• History of allergy/hypersensitivity (including drug allergy) which was deemed relevant to the trial as judged by the investigator
• Positive result for hepatitis B surface antigen (HBsAg), anti hepatitis C virus (HCV), syphilitic test or human immunodeficiency virus (HIV) antigen-antibody test
• 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
• 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
• Participation in another trial with an investigational drug within 4 months prior to administration or during the trial
• Smoker (20 or more cigarettes/day)
• Inability to refrain from smoking during hospitalization
• Alcohol abuse (60 g or more ethanol/day: ex. 3 middle-sized bottles of beer, 3 gous (equivalent to 540 mL) of sake)
• Drug abuse
• Blood donation (more than 100 mL within four weeks prior to administration or during the trial)

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: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2014
• First Posted: October 13, 2014
• Study Start: August 1, 2005
• Primary Completion: October 1, 2005
• Last Updated: October 13, 2014

Record last verified: 2014-10