Clinical trial NCT02209649: Bioavailability of Lacidipine and Telmisartan Fixed Dose Combination Tablets Relative to Separate Tablets in Healthy Subjects
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-08-06
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


Eligibility criteria: 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

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