Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Study to compare the bioavailability of Lacidipine and Telmisartan administered as fixed dose combination tablets with the separate Telmisartan and Lacidipine tablets.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telmisartan and Lacidipine FDC, formulation A | Experimental |
| |
| Telmisartan and Lacidipine FDC, formulation B | Experimental |
| |
| Lacidipine and Telmisartan, mono | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lacidipine and Telmisartan fixed dose combination (FDC) tablet | Drug |
|
| 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 |
Not provided
Not provided
Inclusion Criteria:
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Lacidipine | Drug |
|
| Telmisartan | Drug |
|
| 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 |
| ID | Term |
|---|---|
| C060285 | lacidipine |
| D000077333 | Telmisartan |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided