Single Dose Bioequivalence Study Comparing Nifedipine/Candesartan FDC (Fixed Dose Combination) With Loose Combination of Nifedipine GITS (Gastro-intestinal Therapeutic System) Plus Candesartan and Single Components Under Fasting Conditions
Launched by BAYER · Oct 22, 2010
Trial Information
Current as of May 27, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
MALE
Eligibility criteria
- Inclusion Criteria:
- • Healthy male subject
- • Age: 18 to 45 years (inclusive) at the first screening / examination visit
- • Ethnicity: Caucasian
- • Body mass index (BMI): \>/=18 and \</=29,9 kg/m²
- Exclusion Criteria:
- • Systolic blood pressure below 120 or above 145 mmHg
- • Diastolic blood pressure above 95 mmHg
- • Heart rate below 45 or above 95 beats / min
- • Clinically relevant findings in the physical examination
- • Suspicion of drug or alcohol abuse
- • Regular daily consumption of more than 1 L of xanthin-containing beverages
- • Intake of foods or beverages containing grapefruit within 4 weeks before the pre-study examination
About Bayer
Bayer is a global healthcare and life sciences company dedicated to advancing health and well-being through innovative research and development. With a strong commitment to improving patient outcomes, Bayer conducts clinical trials across various therapeutic areas, including oncology, cardiology, and women's health. The company leverages cutting-edge science and technology to develop breakthrough therapies, while adhering to the highest standards of ethical practices and regulatory compliance. Through collaboration with healthcare professionals and research institutions, Bayer aims to bring transformative solutions to the market, ultimately enhancing the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Köln, Nordrhein Westfalen, Germany
Patients applied
Trial Officials
Bayer Study Director
Study Director
Bayer
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Similar Trials