Influence of Food on the Bioavailability of Two Doses of Telmisartan/HCTZ Fixed-dose Combination in Japanese Healthy Male Volunteers

NCT02276378 | Completed Phase 1

• 1 other identifier: 502.569
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief Summary

To investigate the relative bioavailability and pharmacokinetics of the fixed-dose combination tablets (telmisartan 40 mg/HCTZ 12.5 mg and telmisartan 80 mg/HCTZ 12.5 mg) after food intake in comparison with those in the fasting state in healthy Japanese male volunteers

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Area under the concentration-time curve of the analyte in the plasma over the time interval from 0 to the time of the last quantifiable data point (AUC0-tz)

  Up to 72 hours after drug administration

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

  Up to 72 hours after drug administration

Secondary Outcomes (10)

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

  Up to 72 hours after drug administration

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

  Up to 72 hours after drug administration

• Terminal rate constant in the plasma (λz)

  Up to 72 hours after drug administration

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

  Up to 72 hours after drug administration

• Mean residence time of the analyte in the body after oral administration (MRTpo)

  Up to 72 hours after drug administration

Study Arms (4)

Telmisartan low / HCTZ fixed-dose combination, fed

EXPERIMENTAL

Drug: Telmisartan low; Drug: Hydrochlorothiazide (HCTZ); Other: Japanese meal

Telmisartan high / HCTZ fixed-dose combination, fed

EXPERIMENTAL

Drug: Telmisartan high; Drug: Hydrochlorothiazide (HCTZ); Other: Japanese meal

Telmisartan low /HCTZ fixed-dose combination, fasted

ACTIVE COMPARATOR

Drug: Telmisartan low; Drug: Hydrochlorothiazide (HCTZ)

Telmisartan high /HCTZ fixed-dose combination, fasted

ACTIVE COMPARATOR

Drug: Telmisartan high; Drug: Hydrochlorothiazide (HCTZ)

Interventions

Telmisartan low DRUG

Telmisartan low / HCTZ fixed-dose combination, fed; Telmisartan low /HCTZ fixed-dose combination, fasted

Telmisartan high DRUG

Telmisartan high / HCTZ fixed-dose combination, fed; Telmisartan high /HCTZ fixed-dose combination, fasted

Hydrochlorothiazide (HCTZ) DRUG

Telmisartan high / HCTZ fixed-dose combination, fed; Telmisartan high /HCTZ fixed-dose combination, fasted; Telmisartan low / HCTZ fixed-dose combination, fed; Telmisartan low /HCTZ fixed-dose combination, fasted

Japanese meal OTHER

Telmisartan high / HCTZ fixed-dose combination, fed; Telmisartan low / HCTZ fixed-dose combination, fed

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, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR), body temperature), 12-lead ECG (electrocardiogram), clinical laboratory tests
• Age ≥20 and Age ≤35 years
• Body weight ≥50 kg
• BMI ≥18.0 and BMI ≤25.0 kg/m2 (Body Mass Index)
• Signed and dated written informed consent prior to admission to the study in accordance with Good clinical practice (GCP) and the local legislation.

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 clinical relevant findings of the laboratory test deviating from normal
• Positive result for either hepatitis B surface (HBs) antigen, anti Hepatitis C virus (HCV) antibodies, syphilitic test or human immunodeficiency virus (HIV) test
• History of surgery of gastrointestinal tract (except appendectomy)
• History of relevant orthostatic hypotension, fainting spells or blackouts
• Known hypersensitivity to any component of the formulation (telmisartan and hydrochlorothiazide), or to any other angiotensin II receptor blocker (ARBs), any other thiazides, or thiazide derivatives (e.c. sulfonamide derivatives like a chlorthalidone)
• 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 drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 7 days prior to administration or during the trial
• Participation in another trial with an investigational drug within 4 months or 6 half-lives of the investigational drug prior to administration
• Smoker (≥20 cigarettes/day)
• 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 4 weeks prior to administration or during the trial)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Hydrochlorothiazide

Intervention Hierarchy (Ancestors)

Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Thiazides; 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 27, 2014
• First Posted: October 28, 2014
• Study Start: July 1, 2008
• Primary Completion: August 1, 2008
• Last Updated: October 28, 2014

Record last verified: 2014-10