Bioavailability and proof of concept study of a new modified release losartan formulation versus the marketed formulation Cozaar® administered to healthy volunteers under fasting conditions

DPL Pharma S.p.A.0 sites16 target enrollmentApril 22, 2022

ConditionsBioavailability of a new formulation of losartan Not Applicable

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Bioavailability of a new formulation of losartan
Sponsor: DPL Pharma S.p.A.
Enrollment: 16
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

April 22, 2022

End Date

August 14, 2020

Last Updated

3 years ago

Study Type

Interventional

Sex

Male

Investigators

Sponsor

DPL Pharma S.p.A.

Eligibility Criteria

Inclusion Criteria

•1\. Informed consent: signed written informed consent before inclusion in the study
•2\. Men, 18\-55 years old inclusive
•3\. Body Mass Index: 18\.5\-30 kg/m² inclusive
•4\. Vital signs: systolic blood pressure 100\-139 mmHg, diastolic blood pressure 50\-89 mmHg, heart rate 50\-90 bpm, measured after 5 min at rest in the sitting position
•5\. Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co\-operate with the Investigator and to comply with the requirements of the entire study

Exclusion Criteria

•1\. Electrocardiogram (ECG, 12\-leads, supine position): clinically significant abnormalities
•2\. Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study
•3\. Laboratory analyses: clinically significant abnormal laboratory values indicative of physical illness
•4\. Allergy: ascertained or presumptive hypersensitivity to the active principle and/or formulations' ingredients; history of anaphylaxis to drugs or allergic reactions in general, which the Investigator considers may affect the outcome of the study
•5\. Diseases: significant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases that may interfere with the aim of the study. Known renal dysfunction
•6\. Medications: medications, including over the counter medications and herbal products for 2 weeks before the start of the study
•7\. Investigative drug studies: participation in the evaluation of any investigational product for 3 months before this study. The 3\-month interval is calculated as the time between the first calendar day of the month that follows the last visit of the previous study and the first day of the present study
•8\. Blood donation: blood donations for 3 months before this study
•9\. Drug, alcohol, caffeine, tobacco: history of drug, alcohol (\>2 drinks/day, defined according to the USDA Dietary Guidelines 2015\-2020\), caffeine (\>5 cups coffee/tea/day) or tobacco abuse (\=10 cigarettes/day)
•10\. Drug test: positive result at the drug test at screening or day \-1 (all study periods)