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Search / Trial NCT01227603

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 June 24, 2025

Completed

Keywords

Bioequivalence Nifedipine Candesartan Fdc

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.

Locations

Köln, Nordrhein Westfalen, Germany

Patients applied

0 patients applied

Trial Officials

Bayer Study Director

Study Director

Bayer

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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