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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01227603
First received: October 22, 2010
Last updated: December 8, 2015
Last verified: December 2015
  Purpose
Randomized, open label, single dose, 4-way crossover study to investigate the bioequivalence of a new fixed dose combination tablet of nifedipine GITS and candesartan with the corresponding loose combination and to compare it with the individual drugs

Condition Intervention Phase
Hypertension, Essential Drug: Nifedipine-candesartan FDC (BAY 98-7106) Drug: Nifedipine GITS (Adalat LA, BAYA1040) Drug: Candesartan (Atacand) Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Single Dose Study to Compare the Pharmacokinetics as Well as Safety and Tolerability of a Novel Fixed Dose Combination of Nifedipine GITS and Candesartan, the Loose Combination of Both and the Single Components Alone and to Investigate the Bioequivalence Between the Fixed Dose and the Loose Combination in Healthy Male Volunteers Under Fasting Conditions in an Open Label, Randomized, 4-way-crossover Design

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Cmax [ Time Frame: Within 48 hours after each treatment ]
    Maximum drug concentration in plasma after dose administration for nifedipine and candesartan

  • AUC(0-tn) [ Time Frame: Within 48 hours after each treatment ]
    AUC from time 0 to the last data point for nifedipine and candesartan


Secondary Outcome Measures:
  • AUC [ Time Frame: Within 48 hours after each treatment ]
    Area under the plasma concentration vs time curve from zero to infinity after single (first) dose for nifedipine and candesartan

  • Cmax,norm [ Time Frame: Within 48 hours after each treatment ]
    Maximum drug concentration in plasma after dose administration divided by dose (mg) per kg body weight for nifedipine and candesartan

  • AUCnorm [ Time Frame: Within 48 hours after each treatment ]
    Area under the curve divided by dose per kg body weight for nifedipine and candesartan

  • AUC(0-48) [ Time Frame: Within 48 hours after each treatment ]
    AUC from time 0 to time 48 h for nifedipine and candesartan

  • tmax [ Time Frame: Within 48 hours after each treatment ]
    Time to reach maximum drug concentration in plasma after single (first) dose for nifedipine and candesartan

  • t½ [ Time Frame: Within 48 hours after each treatment ]
    Half-life associated with the terminal slope for nifedipine and candesartan

  • MRT [ Time Frame: Within 48 hours after each treatment ]
    Mean residence time for nifedipine and candesartan

  • CL/f [ Time Frame: Within 48 hours after each treatment ]
    Total body clearance of drug from plasma calculated after oral administration (apparent oral clearance) for nifedipine and candesartan

  • Number of participants with adverse events [ Time Frame: Approximately 3.5 months ]

Enrollment: 49
Study Start Date: November 2010
Study Completion Date: July 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nifedipine-candesartan FDC
Each subject received single fixed dose combination of 60 mg nifedipine and 32 mg candesartan orally.
Drug: Nifedipine-candesartan FDC (BAY 98-7106)
Single dose of 1 FDC tablet consisting of 60 mg nifedipine GITS and 32 mg candesartan
Active Comparator: Nifedipine and candesartan
Each subject received one dose of nifedipine GITS 60 mg and candesartan 32 mg (2 x 16 mg tablet) as loose combination, orally.
Drug: Nifedipine GITS (Adalat LA, BAYA1040)
Single oral dose of 1 tablet of nifedipine GITS 60 mg
Drug: Candesartan (Atacand)
Single oral dose of 32 mg (2 x 16 mg tablet) candesartan
Active Comparator: Nifedipine
Each subject received one dose of nifedipine GITS 60 mg orally.
Drug: Nifedipine GITS (Adalat LA, BAYA1040)
Single oral dose of 1 tablet of nifedipine GITS 60 mg
Active Comparator: Candesartan
Each subject received one dose of candesartan 32 mg (2 x 16 mg tablet), orally.
Drug: Candesartan (Atacand)
Single oral dose of 32 mg (2 x 16 mg tablet) candesartan

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01227603

Locations
Germany
Köln, Nordrhein-Westfalen, Germany, 51063
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Publications:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01227603     History of Changes
Other Study ID Numbers: 14027
2010-021966-31 ( EudraCT Number )
Study First Received: October 22, 2010
Last Updated: December 8, 2015

Keywords provided by Bayer:
Bioequivalence
Nifedipine
Candesartan
FDC

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Nifedipine
Candesartan
Candesartan cilexetil
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on June 23, 2017