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

NCT02262624 | Completed Phase 1

• 1 other identifier: 502.438
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

To establish the bioequivalence of 80 mg telmisartan/12.5 mg HCTZ fixed dose combination vs. 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 (10)

• 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/HCTZ fixed combination

EXPERIMENTAL

Drug: Telmisartan/HCTZ fixed combination

Telmisartan and HCTZ monocomponents

ACTIVE COMPARATOR

Drug: Telmisartan; Drug: Hydrochlorthiazide (HCTZ)

Interventions

Telmisartan DRUG

Telmisartan and HCTZ monocomponents

Hydrochlorthiazide (HCTZ) DRUG

Telmisartan and HCTZ monocomponents

Telmisartan/HCTZ fixed combination DRUG

Telmisartan/HCTZ fixed combination

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 (BP), pulse rate (PR)), 12-lead ECG (electrocardiogram), clinical laboratory tests 1) No finding of clinical relevance 2) No evidence of a clinically relevant concomitant disease
• Age ≥ 20 years and age ≤ 35 years
• 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 in accordance with Good Clinical Practice (GCP) (MHW Ordinance No. 28, as of Mar. 27, 1997) and the local legislation

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 is deemed relevant to the trial as judged by the investigator
• Positive result for Hepatitis B virus surface antigen (HBsAg), anti HCV (Hepatitis C virus), 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 hospitalisation
• 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

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

Record last verified: 2014-10