Relative Oral Bioavailability of Telmisartan / Hydrochlorothiazide (HCTZ) Fixed Dose Combination (FDC) Compared With Its Monocomponents in Healthy Subjects

NCT02187523 | Completed Phase 1

• 1 other identifier: 502.324
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief Summary

A study to demonstrate the bioequivalence of telmisartan and HCTZ administered as fixed dose combination in comparison to the single unit formulations

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• Total area under concentration-time curve of the analytes in plasma from time zero to infinity (AUC0-∞)

  Pre-dose up to day 54

• Maximum concentration of the analytes in plasma (Cmax)

  Pre-dose up to day 54

• Amount of HCTZ excreted in urine over 48 h (Ae(0-48))

  Pre-dose up to day 50

Secondary Outcomes (10)

• time to achieve maximum concentration of the analytes in plasma (tmax)

  Pre-dose up to day 54

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

  Pre-dose up to day 54

• Total clearance of the of the analytes after oral administration (CLtot/f)

  Pre-dose up to day 54

• Total mean residence time of the analytes (MRTtot)

  Pre-dose up to day 54

• Apparent volume of distribution of the analytes during the terminal phase (Vz/f)

  Pre-dose up to day 54

Study Arms (2)

Telmisartan/HCTZ FDC

EXPERIMENTAL

Drug: Telmisartan/HCTZ FDC

Telmisartan and HCTZ individual tablets

ACTIVE COMPARATOR

Drug: Hydrochlorothiazide; Drug: Telmisartan

Interventions

Hydrochlorothiazide DRUG

Telmisartan and HCTZ individual tablets

Telmisartan DRUG

Telmisartan and HCTZ individual tablets

Telmisartan/HCTZ FDC DRUG

Telmisartan/HCTZ FDC

Eligibility Criteria

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

You may qualify if:

• Healthy subjects as determined by results of screening
• Signed written informed consent in accordance with good clinical practice (GCP) and local legislation
• Age ≥ 18 and ≤ 55 years
• Broca ≥ -20 % and ≤ +20 %

You may not qualify if:

• Any findings of the medical examination (including blood pressure, pulse rate and electrocardiogram (ECG)) deviating from normal and of clinical relevance
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Surgery of the gastro-intestinal tract (except appendectomy)
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
• Supine blood pressure at screening of systolic ≤ 110 mmHg and diastolic ≤ 60 mmHg
• History of orthostatic hypotension, fainting, spells or blackouts
• Chronic or relevant acute infection
• History or 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) ≤ 1 month prior to administration or during the trial
• Use of any drugs which might influence the results of the trial (≤ 10 days prior to administration or during the trial)
• Participation in another trial with an investigational drug (≤ 2 months prior to administration or during the trial)
• Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day)
• Inability to refrain from smoking on study days
• Alcohol abuse (\> 60g/day)
• Drug abuse

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Hydrochlorothiazide; Telmisartan

Intervention Hierarchy (Ancestors)

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

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: July 9, 2014
• First Posted: July 11, 2014
• Study Start: October 1, 1999
• Primary Completion: December 1, 1999
• Last Updated: July 11, 2014

Record last verified: 2014-07