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

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 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01350609
• Other study ID #: 14028
• Secondary ID: 2011-000322-29
• Status: Completed
• Phase: Phase 1
• First received: April 18, 2011
• Last updated: December 8, 2015
• Start date: April 2011
• Est. completion date: September 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 (BfArM)
• Study type: Interventional

Clinical Trial 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.

Description:

Clinical pharmacology

Recruitment information / eligibility

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

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Essential

Intervention

Drug:
• Nifedipine/Candesartan (BAY 98-7106)
Fixed dose combination of 60 mg nifedipine + 32 mg candesartan (1 tablet in one period)
• Nifedipine (Adalat, BAY A1040) and Candesartan (Atacand, BAY 12-9333)
Loose combination of 1 tablet nifedpipine 60mg (Adalat LA) and 2 tablets candesartan 16mg (Atacand) (3 tablets in one period) .

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

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 dosing	No
Primary	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	No
Secondary	AUC	Area under the curve from time 0 to infinity after single dose for nifedipine and candesartan	Within 48 hours after each dosing	No
Secondary	Cmax,norm	Dose normalized Cmax for nifedipine and candesartan	Within 48 hours after each dosing	No
Secondary	AUCnorm	AUC normalized for dose and body weight for nifedipine and candesartan	Within 48 hours after each dosing	No
Secondary	AUC(0-48)	Area under the plasma concentration-time curve from time zero to 48h for nifedipine and candesartan	Within 48 hours after each dosing	No
Secondary	Tmax	The time of the maximum concentration for nifedipine and candesartan	Within 48 hours after each dosing	No
Secondary	t1/2	Half-life for nifedipine and candesartan	Within 48 hours after each dosing	No
Secondary	MRT	The mean residence time for nifedipine and candesartan	Within 48 hours after each dosing	No
Secondary	CL/F	Oral plasma clearances for nifedipine and candesartan	Within 48 hours after each dosing	No
Secondary	Number of participants with adverse events		Approximately 3-7 weeks per subject	Yes

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