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

NCT02209649 | Completed Phase 1

• 1 other identifier: 1173.6
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (13)

• 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

Study Arms (3)

Telmisartan and Lacidipine FDC, formulation A

EXPERIMENTAL

Drug: Lacidipine and Telmisartan fixed dose combination (FDC) tablet

Telmisartan and Lacidipine FDC, formulation B

EXPERIMENTAL

Drug: Lacidipine and Telmisartan fixed dose combination (FDC) tablet

Lacidipine and Telmisartan, mono

ACTIVE COMPARATOR

Drug: Lacidipine; Drug: Telmisartan

Interventions

Lacidipine and Telmisartan fixed dose combination (FDC) tablet DRUG

Telmisartan and Lacidipine FDC, formulation A; Telmisartan and Lacidipine FDC, formulation B

Lacidipine DRUG

Lacidipine and Telmisartan, mono

Telmisartan DRUG

Lacidipine and Telmisartan, mono

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
• Age ≥ 18 and ≤ 50 years
• Broca ≥ - 20 % and ≤ + 20 %
• Written informed consent in accordance with Good Clinical Practice and local legislation given

You may not qualify if:

• 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)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

lacidipine; Telmisartan; Tablets

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; Dosage Forms; Pharmaceutical Preparations

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: August 5, 2014
• First Posted: August 6, 2014
• Study Start: October 1, 1999
• Primary Completion: December 1, 1999
• Last Updated: August 6, 2014

Record last verified: 2014-08