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

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

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Lacidipine and Telmisartan fixed dose combination (FDC) tablet
* Drug: Lacidipine
* Drug: Telmisartan


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telmisartan and Lacidipine FDC, formulation A<br> | Drug: Lacidipine and Telmisartan fixed dose combination (FDC) tablet<br> <br> |
| Experimental: Telmisartan and Lacidipine FDC, formulation B<br> | Drug: Lacidipine and Telmisartan fixed dose combination (FDC) tablet<br> <br> |
| Active Comparator: Lacidipine and Telmisartan, mono<br> | Drug: Lacidipine<br> <br> Drug: Telmisartan<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |