Study to assess the distribution in the blood of healthy volunteers of a new formulation of losartan compared with the marketed formulation Cozaar® administered under fasting conditions

Phase 1

Completed

• Conditions: Bioavailability of a new formulation of losartan; Not Applicable

• Registration Number: ISRCTN16928142
• Lead Sponsor: DPL Pharma S.p.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-08-14
• Study Start: 2022-04-22
• Last Update Posted: 9 May 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 16

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)
11. Alcohol test: positive alcohol breath test at day -1 (all study periods)
12. Diet: abnormal diets (<1600 or >3500 kcal/day) or substantial changes in eating habits in the 4 weeks before this study; vegetarians

Study & Design

• Study Type: Interventional
• Study Design: Not specified