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

Tolerability and Pharmacokinetics of 80 mg Telmisartan and 6 mg Lacidipine Alone and in Combination After 7 Days Treatment. An Open Randomised Three-way Cross-over Trial in Female and Male Healthy Subjects

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Telmisartan; Drug: Lacidipine

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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%

Exclusion Criteria:

• 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)
• Any laboratory value outside the reference range of clinical relevance

• Female only:

  • no reliable contraception (reliable are: oral contraceptives, 3-month injection, Intrauterine devices (IUD), sterilization)
  • Pregnancy or breast feeding period

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Telmisartan	Drug: Telmisartan
Experimental: Lacidipine	Drug: Lacidipine
Experimental: Lacidipine + Telmisartan	Drug: Telmisartan; Drug: Lacidipine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cmax (Maximum measured concentration 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
t½ (Terminal half-life of the analyte in plasma)	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
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
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
CL/F (Apparent clearance of the analyte in plasma following extravascular administration) )	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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: October 1, 1998
• Primary Completion (Actual): January 1, 1999

Study Registration Dates

• First Submitted: July 29, 2014
• First Submitted That Met QC Criteria: July 29, 2014
• First Posted (Estimate): July 30, 2014

Study Record Updates

• Last Update Posted (Estimate): August 6, 2014
• Last Update Submitted That Met QC Criteria: August 5, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Telmisartan; Lacidipine
• Other Study ID Numbers: 1173.2