Tolerability and Pharmacokinetics of Telmisartan in Combination With Lacidipine in Healthy Male Subjects

NCT02218684 | Completed Phase 1

• 1 other identifier: 1173.1
• Study Type: interventional
• Target: 27
• Locations: 0 countries
• Sites: N/A

Brief Summary

The trial objectives were to investigate the tolerability and pharmacokinetics of 80 mg telmisartan and 2, 4 or 6 mg lacidipine administered concurrently.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

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

  up to 72 hours after drug administration

• Number of subjects with adverse events

  up to 72 hours after drug administration

Secondary Outcomes (8)

• AUC (Area under the concentration-time curve of the analyte in plasma)

  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

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

  up to 72 hours after drug administration

• Vz/F (Apparent volume of distribution of the analyte during the terminal phase)

  up to 72 hours after drug administration

• MRT (Mean residence time of the analyte in the body)

  up to 72 hours after drug administration

Study Arms (4)

Telmisartan + Lacidipine - low dose

EXPERIMENTAL

Drug: Telmisartan; Drug: Lacidipine

Telmisartan + Lacidipine - medium dose

EXPERIMENTAL

Drug: Telmisartan; Drug: Lacidipine

Telmisartan + Lacidipine - high dose

EXPERIMENTAL

Drug: Telmisartan; Drug: Lacidipine

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Telmisartan DRUG

Telmisartan + Lacidipine - high dose; Telmisartan + Lacidipine - low dose; Telmisartan + Lacidipine - medium dose

Lacidipine DRUG

Telmisartan + Lacidipine - high dose; Telmisartan + Lacidipine - low dose; Telmisartan + Lacidipine - medium dose

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male caucasian subjects as determined by results of screening
• Written informed consent in accordance with Good Clinical Practice and local legislation given
• Age \>= 18 and \<= 50 years
• Broca \>= -20% and \<= + 20%

You may not qualify if:

• Any finding 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 gastrointestinal tract (except appendectomy)
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurologic disorders
• History of 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
• 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
• Blood donation \> 100 ml (\<= 4 weeks prior to administration or during the trial)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Telmisartan; lacidipine

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: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2014
• First Posted: August 18, 2014
• Study Start: September 1, 1998
• Primary Completion: November 1, 1998
• Last Updated: August 18, 2014

Record last verified: 2014-07