Bioavailability of Lacidipine and Telmisartan Fixed Dose Combination Tablets Relative to Separate Tablets in Healthy Subjects

Bioavailability of Lacidipine 4 mg and Telmisartan 40 mg Administered Orally as Two Experimental Fixed Dose Combination Tablets Relative to Separate Tablets. An Open Randomised Three-way Cross-over Steady State Trial in 6 Female and 6 Male Healthy Subjects

Study to compare the bioavailability of Lacidipine and Telmisartan administered as fixed dose combination tablets with the separate Telmisartan and Lacidipine tablets.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Telmisartan; Drug: Lacidipine and Telmisartan fixed dose combination (FDC) tablet; Drug: Lacidipine

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy male and female Caucasian subjects as determined by results of screening
• Age ≥ 18 and ≤ 50 years
• Broca ≥ - 20 % and ≤ + 20 %
• Written informed consent in accordance with Good Clinical Practice and local legislation given

Exclusion Criteria:

• Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram) deviating from normal and of clinical relevance
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Surgery of gastrointestinal tract (except appendectomy)
• Disease 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, except for oral contraceptives)
• Use of any drugs which might influence the results of the trial (≤ 10 days prior to administration or during the trial except for oral contraceptives)
• 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 trial days
• Alcohol abuse (> 60 g/day)
• Blood donation > 100 ml (≤ 4 weeks prior to administration or during the trial)
• Excessive physical activities (≤ 10 days prior to administration or during the trial)
• Any laboratory value outside the reference range of clinical relevance

• Females only:

  • no reliable contraception (e.g. oral contraceptives, 3-month injection, intrauterine device, sterilisation)
  • pregnancy of 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 and Lacidipine FDC, formulation A	Drug: Lacidipine and Telmisartan fixed dose combination (FDC) tablet
Experimental: Telmisartan and Lacidipine FDC, formulation B	Drug: Lacidipine and Telmisartan fixed dose combination (FDC) tablet
Active Comparator: Lacidipine and Telmisartan, mono	Drug: Telmisartan; Drug: Lacidipine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area under the curve at steady state (AUCss)	up to 72 hours after drug administration at day 7
Maximum concentration (Cmax,ss)	up to 72 hours after drug administration at day 7
Time to maximum concentration (tmax)	up to 72 hours after drug administration at day 7
Total apparent clearance (CLtot/f)	up to 72 hours after drug administration at day 7
Apparent volume of distribution (Vz/f)	up to 72 hours after drug administration at day 7
Mean residence time (MRTss)	up to 72 hours after drug administration at day 7
Terminal half-life (t1/2)	up to 72 hours after drug administration at day 7
Number of patients with adverse events	up to 66 days
Number of patients with abnormal findings in physical examination	up to 66 days
Number of patients with clinically relevant changes in electrocardiogram	up to 66 days
Number of patients with clinically relevant changes in vital signs	up to 66 days
Number of patients with abnormal changes in laboratory parameters	up to 66 days
Assessment of tolerability on a verbal rating scale	between day 3 and 5 after last study drug administration

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

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

Study Registration Dates

• First Submitted: August 5, 2014
• First Submitted That Met QC Criteria: August 5, 2014
• First Posted (Estimate): August 6, 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: 1173.6