Back to results

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

Primary Purpose

Hypertension, Essential

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

Nifedipine-candesartan FDC (BAY 98-7106)

Nifedipine GITS (Adalat LA, BAYA1040)

Candesartan (Atacand)

About this trial

This is an interventional treatment trial for Hypertension, Essential focused on measuring Bioequivalence, Nifedipine, Candesartan, FDC

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Arm Label

Nifedipine-candesartan FDC

Nifedipine and candesartan

Nifedipine

Candesartan

Arm Description

Each subject received single fixed dose combination of 60 mg nifedipine and 32 mg candesartan orally.

Each subject received one dose of nifedipine GITS 60 mg and candesartan 32 mg (2 x 16 mg tablet) as loose combination, orally.

Each subject received one dose of nifedipine GITS 60 mg orally.

Each subject received one dose of candesartan 32 mg (2 x 16 mg tablet), orally.

Outcomes

Primary Outcome Measures

Cmax

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

AUC(0-tn)

AUC from time 0 to the last data point for nifedipine and candesartan

Secondary Outcome Measures

AUC

Area under the plasma concentration vs time curve from zero to infinity after single (first) dose for nifedipine and candesartan

Cmax,norm

Maximum drug concentration in plasma after dose administration divided by dose (mg) per kg body weight for nifedipine and candesartan

AUCnorm

Area under the curve divided by dose per kg body weight for nifedipine and candesartan

AUC(0-48)

AUC from time 0 to time 48 h for nifedipine and candesartan

tmax

Time to reach maximum drug concentration in plasma after single (first) dose for nifedipine and candesartan

t½

Half-life associated with the terminal slope for nifedipine and candesartan

MRT

Mean residence time for nifedipine and candesartan

CL/f

Total body clearance of drug from plasma calculated after oral administration (apparent oral clearance) for nifedipine and candesartan

Number of participants with adverse events

Full Information

NCT ID

NCT01227603

First Posted

October 22, 2010

Last Updated

December 8, 2015

Sponsor

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT01227603

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Completed

Study Start Date

November 2010 (undefined)

Primary Completion Date

March 2011 (Actual)

Study Completion Date

July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bayer

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension, Essential

Keywords

Bioequivalence, Nifedipine, Candesartan, FDC

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

49 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nifedipine-candesartan FDC

Arm Type

Experimental

Arm Description

Each subject received single fixed dose combination of 60 mg nifedipine and 32 mg candesartan orally.

Arm Title

Nifedipine and candesartan

Arm Type

Active Comparator

Arm Description

Each subject received one dose of nifedipine GITS 60 mg and candesartan 32 mg (2 x 16 mg tablet) as loose combination, orally.

Arm Title

Nifedipine

Arm Type

Active Comparator

Arm Description

Each subject received one dose of nifedipine GITS 60 mg orally.

Arm Title

Candesartan

Arm Type

Active Comparator

Arm Description

Each subject received one dose of candesartan 32 mg (2 x 16 mg tablet), orally.

Intervention Type

Drug

Intervention Name(s)

Nifedipine-candesartan FDC (BAY 98-7106)

Intervention Description

Single dose of 1 FDC tablet consisting of 60 mg nifedipine GITS and 32 mg candesartan

Intervention Type

Drug

Intervention Name(s)

Nifedipine GITS (Adalat LA, BAYA1040)

Intervention Description

Single oral dose of 1 tablet of nifedipine GITS 60 mg

Intervention Type

Drug

Intervention Name(s)

Candesartan (Atacand)

Intervention Description

Single oral dose of 32 mg (2 x 16 mg tablet) candesartan

Primary Outcome Measure Information:

Title

Cmax

Description

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

Time Frame

Within 48 hours after each treatment

Title

AUC(0-tn)

Description

AUC from time 0 to the last data point for nifedipine and candesartan

Time Frame

Within 48 hours after each treatment

Secondary Outcome Measure Information:

Title

AUC

Description

Area under the plasma concentration vs time curve from zero to infinity after single (first) dose for nifedipine and candesartan

Time Frame

Within 48 hours after each treatment

Title

Cmax,norm

Description

Maximum drug concentration in plasma after dose administration divided by dose (mg) per kg body weight for nifedipine and candesartan

Time Frame

Within 48 hours after each treatment

Title

AUCnorm

Description

Area under the curve divided by dose per kg body weight for nifedipine and candesartan

Time Frame

Within 48 hours after each treatment

Title

AUC(0-48)

Description

AUC from time 0 to time 48 h for nifedipine and candesartan

Time Frame

Within 48 hours after each treatment

Title

tmax

Description

Time to reach maximum drug concentration in plasma after single (first) dose for nifedipine and candesartan

Time Frame

Within 48 hours after each treatment

Title

t½

Description

Half-life associated with the terminal slope for nifedipine and candesartan

Time Frame

Within 48 hours after each treatment

Title

MRT

Description

Mean residence time for nifedipine and candesartan

Time Frame

Within 48 hours after each treatment

Title

CL/f

Description

Total body clearance of drug from plasma calculated after oral administration (apparent oral clearance) for nifedipine and candesartan

Time Frame

Within 48 hours after each treatment

Title

Number of participants with adverse events

Time Frame

Approximately 3.5 months

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bayer Study Director

Organizational Affiliation

Bayer

Official's Role

Study Director

Facility Information:

City

Köln

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

51063

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

23849325

Citation

Brendel E, Weimann B, Dietrich H, Froede C, Thomas D. Investigation of bioequivalence of a new fixed-dose combination of nifedipine and candesartan with the corresponding loose combination as well as the drug-drug interaction potential between both drugs under fasting conditions. Int J Clin Pharmacol Ther. 2013 Sep;51(9):753-62. doi: 10.5414/CP201879.

Results Reference

result

Links:

URL

http://www.clinicaltrialsregister.eu/

Description

Click here to find information about studies related to Bayer Healthcare products conducted in Europe.

Learn more about this trial

We'll reach out to this number within 24 hrs