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.
Information provided by (Responsible Party):
Bayer Identifier:
First received: October 22, 2010
Last updated: May 12, 2015
Last verified: May 2015
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
Drug: Nifedipine/Candesartan (BAY98-7106)
Drug: Nifedipine (Adalat, BAYA1040) + Candesartan
Drug: Nifedipine (Adalat, BAYA1040)
Drug: Candesartan
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
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:
  • C(max) and AUC(0-tn) for nifedipine [ Time Frame: Within 48 hours after each treatment ] [ Designated as safety issue: No ]
  • C(max) and AUC(0-tn) for candesartan [ Time Frame: Within 48 hours after each treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Further pharmakokinetic parameters (AUC, C(max,norm), AUCnorm, AUC(0-48), tmax and t1/2) for nifedipine and candesartan [ Time Frame: Within 48 hours after each treatment ] [ Designated as safety issue: No ]

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: Arm 1 Drug: Nifedipine/Candesartan (BAY98-7106)
Single dose of 1 FDC tablet consisting of 60 mg nifedipine GITS and 32 mg candesartan
Active Comparator: Arm 2 Drug: Nifedipine (Adalat, BAYA1040) + Candesartan
Single oral dose of 1 tablet of nifedipine GITS 60 mg given together with 1 tablet of candesartan 32 mg
Active Comparator: Arm 3 Drug: Nifedipine (Adalat, BAYA1040)
Single oral dose of 1 tablet of nifedipine GITS 60 mg
Active Comparator: Arm 4 Drug: Candesartan
Single oral dose of 1 tablet of candesartan 32 mg


Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its identifier: NCT01227603

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

Additional Information:
No publications provided by Bayer

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Bayer Identifier: NCT01227603     History of Changes
Other Study ID Numbers: 14027, 2010-021966-31
Study First Received: October 22, 2010
Last Updated: May 12, 2015
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:

Additional relevant MeSH terms:
Candesartan cilexetil
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Antihypertensive Agents
Calcium Channel Blockers
Cardiovascular Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses
Tocolytic Agents
Vasodilator Agents processed this record on November 25, 2015