Pivotal Bioequivalence FDC Nifedipine / Candesartan vs. Loose Combination of Single Components, Fed

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01350609
First received: April 18, 2011
Last updated: July 14, 2014
Last verified: July 2014
  Purpose

Randomized, open label, single dose, 2-way crossover study to investigate the bioequivalence of a new fixed dose combination (FDC) tablet of nifedipine GITS and candesartan with the corresponding loose combination under fed conditions.


Condition Intervention Phase
Hypertension
Drug: Nifedipine/Candesartan, BAY98-7106
Drug: Nifedipine (Adalat, BAYA1040) and Candesartan(Atacand,BAY12-9333)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
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 and the Loose Combination of Both Components and to Investigate the Bioequivalence Between the Fixed Dose and the Loose Combination in Healthy Male Subjects Under Fed Conditions in an Open Label, Randomized, 2-way-crossover Design

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Maximum drug concentration in plasma (Cmax) of nifedipine and candesartan [ Time Frame: within 48 hours after each dosing ] [ Designated as safety issue: No ]
  • Area under the drug-concentration vs. time curve from time 0 to the last data point (AUC(0 tn)) of nifedipine and candesartan [ Time Frame: within 48 hours after each dosing ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Area under the curve (AUC) of Nifedipine and Candesartan [ Time Frame: Within 48 hours after each dosing ] [ Designated as safety issue: No ]
  • Dose normalized Cmax (Cmax,norm) of Nifedipine and Candesartan [ Time Frame: Within 48 hours after each dosing ] [ Designated as safety issue: No ]
  • AUC normalized for dose and body weight (AUCnorm) of Nifedipine and Candesartan [ Time Frame: Within 48 hours after each dosing ] [ Designated as safety issue: No ]
  • Area under the plasma concentration-time curve from time zero to 48h (AUC(0-48))of Nifedipine and Candesartan [ Time Frame: Within 48 hours after each dosing ] [ Designated as safety issue: No ]
  • The time of the maximum concentration (Tmax) of Nifedipine and Candesartan [ Time Frame: Within 48 hours after each dosing ] [ Designated as safety issue: No ]
  • Half life (t1/2) of Nifedipine and Candesartan [ Time Frame: Within 48 hours after each dosing ] [ Designated as safety issue: No ]
  • The mean residence time (MRT) of Nifedipine and Candesartan [ Time Frame: Within 48 hours after each dosing ] [ Designated as safety issue: No ]
  • Oral plasma clearances (CL/F) of Nifedipine and Candesartan [ Time Frame: Within 48 hours after each dosing ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: April 2011
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Nifedipine/Candesartan, BAY98-7106
Fixed dose combination of 60 mg nifedipine + 32 mg candesartan (1 tablet in one period)
Active Comparator: Arm 2 Drug: Nifedipine (Adalat, BAYA1040) and Candesartan(Atacand,BAY12-9333)
Loose combination of 1 tablet nifedpipine 60mg (Adalat LA) and 2 tablets candesartan 16mg (Atacand) (3 tablets in one period) .

  Eligibility

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

Inclusion Criteria:

  • The informed consent form must be signed before any study specific tests or procedures are done
  • Confirmation of the subject's health insurance coverage prior to the first screening visit
  • Healthy male subject
  • Ethnicity: Caucasian
  • Age: 18 to 45 years (inclusive) at the first screening visit
  • Body mass index (BMI) above or equal 18, and below or equal 29.9 kg / m²
  • Ability to understand and follow study-related instructions

Exclusion Criteria:

  • 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 2 weeks prior to the first study drug administration (the same applies to pomelos and St. John's Wort)
  • Use of medication within 4 weeks prior to the first study drug administration which could interfere with the investigational products (e.g. CYP3A inhibitors or CYP3A inducers)

    • examples for CYP3A inhibitors: erythromycin, inhibitors of human HIV protease (e.g. ritonavir, saquinavir), amiodarone, diltiazem, verapamil, fluconazole, itraconazole, ketoconazole, clarithromycin, telithromycin, nefazodon, cimetidine;
    • examples for CYP3A inducers: rifampicin, carbamazepin, phenytoin, phenobarbital, or products containing St. John's Wort;
  • Systolic blood pressure below 116 or above 145 mmHg (after at least 15 min supine)
  • At the first screening visit

    • Diastolic blood pressure above 95 mmHg (after at least 15 min supine)
    • Heart rate below 45 or above 95 beats / min (after at least 15 min supine) at the first screening visit
    • Clinically relevant findings in the physical examination
    • Positive urine drug screening or alcohol breath test
  • Exclusion periods from other studies or simultaneous participation in other clinical studies
  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: NCT01350609

Locations
Germany
Berlin, Germany, 13353
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01350609     History of Changes
Other Study ID Numbers: 14028, 2011-000322-29
Study First Received: April 18, 2011
Last Updated: July 14, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices (BfArM)

Keywords provided by Bayer:
essential hypertension, blood pressure, 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
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
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 August 28, 2014