NCT Number: NCT02218684
Tolerability and Pharmacokinetics of Telmisartan in Combination With Lacidipine in Healthy Male Subjects
The trial objectives were to investigate the tolerability and pharmacokinetics of 80 mg telmisartan and 2, 4 or 6 mg lacidipine administered concurrently.
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Conditions
Age range
18 year–50 year
Sex eligibility
Male
Study type
Interventional
Phase
Phase 1
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Healthy male caucasian subjects as determined by results of screening
- Written informed consent in accordance with Good Clinical Practice and local legislation given
- Age >= 18 and <= 50 years
- Broca >= -20% and <= + 20%
Exclusion criteria
- Any finding of the medical examination (including blood pressure, pulse rate and Electrocardiogram (ECG) deviating from normal and of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Surgery of gastrointestinal tract (except appendectomy)
- Diseases 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)
- Use of any drugs which might influence the results of the trial (<= 10 days prior to administration or during the trial)
- 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 study days
- Alcohol abuse (> 60g/day)
- Drug abuse
- 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
Treatment and study plan
Lacidipine
DrugPlacebo
DrugPrimary outcomes
-
Cmax (Maximum measured concentration of the analyte in plasma)
Time frame: up to 72 hours after drug administration
-
Number of subjects with adverse events
Time frame: up to 72 hours after drug administration
Secondary outcomes
-
AUC (Area under the concentration-time curve of the analyte in plasma)
Time frame: up to 72 hours after drug administration
-
tmax (Time from dosing to the maximum concentration of the analyte in plasma)
Time frame: up to 72 hours after drug administration
-
CL/F (Apparent clearance of the analyte in plasma following extravascular administration)
Time frame: up to 72 hours after drug administration
-
Vz/F (Apparent volume of distribution of the analyte during the terminal phase)
Time frame: up to 72 hours after drug administration
-
MRT (Mean residence time of the analyte in the body)
Time frame: up to 72 hours after drug administration
-
t½ (Terminal half-life of the analyte in plasma)
Time frame: up to 72 hours after drug administration
-
Number of subjects with abnormal changes in laboratory parameters
Time frame: up to 72 hours after drug administration
-
Number of subjects with clinically significant changes in vital signs
Time frame: up to 72 hours after drug administration
Sponsors and collaborators
Lead sponsor
Boehringer Ingelheim
Industry
Registry information
Official study title
Tolerability and Pharmacokinetics of 80 mg Telmisartan in Combination With 2, 4, or 6 mg Lacidipine. An Open, Single Rising Dose Group Comparison Trial - Placebo Randomised Double Blind in Each Dose Group - in Male Healthy Subjects
Important dates
- Study start
- 1998
- Primary completion
- 1998
- First posted
- Aug 18, 2014
- Registry last updated
- Aug 18, 2014
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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