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

Hypertension, Essential Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01227603
• Other study ID #: 14027
• Secondary ID: 2010-021966-31
• Status: Completed
• Phase: Phase 1
• First received: October 22, 2010
• Last updated: December 8, 2015
• Start date: November 2010
• Est. completion date: July 2011

Study information

• Verified date: December 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: July 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Essential

Intervention

Drug:
• Nifedipine-candesartan FDC (BAY 98-7106)
Single dose of 1 FDC tablet consisting of 60 mg nifedipine GITS and 32 mg candesartan
• Nifedipine GITS (Adalat LA, BAYA1040)
Single oral dose of 1 tablet of nifedipine GITS 60 mg
• Candesartan (Atacand)
Single oral dose of 32 mg (2 x 16 mg tablet) candesartan

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax	Maximum drug concentration in plasma after dose administration for nifedipine and candesartan	Within 48 hours after each treatment	No
Primary	AUC(0-tn)	AUC from time 0 to the last data point for nifedipine and candesartan	Within 48 hours after each treatment	No
Secondary	AUC	Area under the plasma concentration vs time curve from zero to infinity after single (first) dose for nifedipine and candesartan	Within 48 hours after each treatment	No
Secondary	Cmax,norm	Maximum drug concentration in plasma after dose administration divided by dose (mg) per kg body weight for nifedipine and candesartan	Within 48 hours after each treatment	No
Secondary	AUCnorm	Area under the curve divided by dose per kg body weight for nifedipine and candesartan	Within 48 hours after each treatment	No
Secondary	AUC(0-48)	AUC from time 0 to time 48 h for nifedipine and candesartan	Within 48 hours after each treatment	No
Secondary	tmax	Time to reach maximum drug concentration in plasma after single (first) dose for nifedipine and candesartan	Within 48 hours after each treatment	No
Secondary	t½	Half-life associated with the terminal slope for nifedipine and candesartan	Within 48 hours after each treatment	No
Secondary	MRT	Mean residence time for nifedipine and candesartan	Within 48 hours after each treatment	No
Secondary	CL/f	Total body clearance of drug from plasma calculated after oral administration (apparent oral clearance) for nifedipine and candesartan	Within 48 hours after each treatment	No
Secondary	Number of participants with adverse events		Approximately 3.5 months	Yes

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