Tolerability and Pharmacokinetics of Lacidipine With and Without the Co-administration of Telmisartan in Female and Male Healthy Subjects

NCT02203500 | Completed Phase 1

• 1 other identifier: 1173.2
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objectives of this study are to compare the steady state pharmacokinetics of lacidipine with and without the co-administration of telmisartan and to compare the steady state pharmacokinetics of telmisartan with and without the co-administration of lacidipine

Conditions

Healthy

Outcome Measures

Primary Outcomes (11)

• Number of subjects with clinically significant changes in vital signs

  up to 12 days after last drug administration

• Number of subjects with abnormal changes in laboratory parameters

  up to 12 days after last drug administration

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

  up to 72 hours after drug administration

• Cmin (Minimum measured concentration of the analyte in plasma)

  up to 72 hours after drug administration

• AUCss (Area under the concentration-time curve of the analyte in plasma at steady state)

  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

• t½ (Terminal half-life of the analyte in plasma)

  up to 72 hours after drug administration

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

  up to 72 hours after drug administration

• Number of subjects with adverse events

  up to 66 days

Study Arms (3)

Lacidipine

EXPERIMENTAL

Drug: Lacidipine

Telmisartan

EXPERIMENTAL

Drug: Telmisartan

Lacidipine + Telmisartan

EXPERIMENTAL

Drug: Lacidipine; Drug: Telmisartan

Interventions

Lacidipine DRUG

Lacidipine; Lacidipine + Telmisartan

Telmisartan DRUG

Lacidipine + Telmisartan; Telmisartan

Eligibility Criteria

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

You may qualify if:

• Healthy male and female 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

lacidipine; 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: July 29, 2014
• First Posted: July 30, 2014
• Study Start: October 1, 1998
• Primary Completion: January 1, 1999
• Last Updated: August 6, 2014

Record last verified: 2014-08