NCT01350609

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2011

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

April 18, 2011

Completed
22 days until next milestone

First Posted

Study publicly available on registry

May 10, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

December 10, 2015

Status Verified

December 1, 2015

Enrollment Period

4 months

First QC Date

April 18, 2011

Last Update Submit

December 8, 2015

Conditions

Hypertension, Essential

Keywords

essential hypertension, blood pressure, nifedipine, candesartan, FDC

Outcome Measures

Primary Outcomes (2)

  • Cmax

    Maximum drug concentration in plasma after dose administration for nifedipine and candesartan

    within 48 hours after each dosing

  • AUC(0-tlast)

    Area under the drug-concentration vs. time curve from time 0 to the last data point for nifedipine and candesartan

    within 48 hours after each dosing

Secondary Outcomes (9)

  • AUC

    Within 48 hours after each dosing

  • Cmax,norm

    Within 48 hours after each dosing

  • AUCnorm

    Within 48 hours after each dosing

  • AUC(0-48)

    Within 48 hours after each dosing

  • Tmax

    Within 48 hours after each dosing

  • +4 more secondary outcomes

Study Arms (2)

Nifedipine/Candesartan (fixed dose)

EXPERIMENTAL
Drug: Nifedipine/Candesartan (BAY 98-7106)

Nifedipine/Candesartan (loose)

ACTIVE COMPARATOR
Drug: Nifedipine (Adalat, BAY A1040) and Candesartan (Atacand, BAY 12-9333)

Interventions

Nifedipine/Candesartan (BAY 98-7106)DRUG

Fixed dose combination of 60 mg nifedipine + 32 mg candesartan (1 tablet in one period)

Nifedipine/Candesartan (fixed dose)
Nifedipine (Adalat, BAY A1040) and Candesartan (Atacand, BAY 12-9333)DRUG

Loose combination of 1 tablet nifedpipine 60mg (Adalat LA) and 2 tablets candesartan 16mg (Atacand) (3 tablets in one period) .

Nifedipine/Candesartan (loose)

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Berlin, State of Berlin, 13353, Germany

Location

Related Links

MeSH Terms

Conditions

Essential Hypertension

Interventions

Nifedipinecandesartancandesartan cilexetil

Condition Hierarchy (Ancestors)

HypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2011

First Posted

May 10, 2011

Study Start

April 1, 2011

Primary Completion

August 1, 2011

Study Completion

September 1, 2011

Last Updated

December 10, 2015

Record last verified: 2015-12

Locations

DE(1)