Relative Bioavailability of Telmisartan and HCTZ in Two Experimental Formulations Compared to the Standard Formulation Telmisartan and HCTZ in Healthy Female and Male Subjects

NCT02262572 | Completed Phase 1

• 1 other identifier: 502.415
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study to assess the comparative pharmacokinetics of telmisartan/HCTZ in two new formulations based on sodium salt compared to the present commercial formulation (MicardisPlus®)

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• 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

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

  up to 72 hours after drug administration

• Amount of HCTZ excreted in urine over 48 hours (%Ae0-48h)

  up to 48 hours after drug administration

Secondary Outcomes (9)

• tmax (Time from dosing to the maximum concentration 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

• CLtot/F (Apparent clearance of the analyte in plasma following extravascular administration)

  up to 72 hours after drug administration

• MRTtot (Total mean residence time)

  up to 72 hours after drug administration

• Vz/F (Apparent volume of distribution during the terminal phase λz following an extravascular dose)

  up to 72 hours after drug administration

Study Arms (3)

Telmisartan /HCTZ - compression tablet (DC)

EXPERIMENTAL

Drug: Telmisartan /HCTZ - compression tablet (DC)

Telmisartan /HCTZ - dry granulation tablet (DG)

EXPERIMENTAL

Drug: Telmisartan /HCTZ - dry granulation tablet (DG)

Telmisartan /HCTZ - present commercial formulation

ACTIVE COMPARATOR

Drug: Telmisartan /HCTZ - present commercial formulation

Interventions

Telmisartan /HCTZ - compression tablet (DC) DRUG

Telmisartan /HCTZ - compression tablet (DC)

Telmisartan /HCTZ - dry granulation tablet (DG) DRUG

Telmisartan /HCTZ - dry granulation tablet (DG)

Telmisartan /HCTZ - present commercial formulation DRUG

Also known as: MicardisPlus®

Telmisartan /HCTZ - present commercial formulation

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects meeting the following criteria will be eligible for participation in the study:
• Healthy male and female subjects according to the following criteria: based upon a complete medical history, including the physical examination, vital signs (BP, HR), 12-lead ECG, clinical laboratory tests.
• Laboratory values within a clinically defined reference range
• Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation
• Age \>=18 and Age \<=55 years
• Body mass index (BMI) \>=18.5 and \<=29.9 kg/m2
• Able to communicate well with the investigator and to comply with study requirements
• Good condition of veins

You may not qualify if:

• Any finding of the medical examination (including blood pressure, heart rate, and electrocardiogram) deviating from normal and of clinical relevance
• Supine blood pressure at screening of systolic ≤ 110 mm Hg and diastolic ≤ 60 mmHg
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic 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 an allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
• 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 any 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 two months prior to administration or during the trial
• Smoker (more than 10 cigarettes or three cigars or three pipes/day)
• Alcohol abuse (more than 60 g/day)
• Drug abuse
• Blood donation or loss of more than 400 mL within four weeks prior to administration or during the trial

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Telmisartan; telmisartan, hydrochlorothiazide drug combination

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

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 9, 2014
• First Posted: October 13, 2014
• Study Start: April 1, 2003
• Primary Completion: August 1, 2003
• Last Updated: October 13, 2014

Record last verified: 2014-10