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

Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: Nifedipine/Candesartan (BAY 98-7106) (Drug); Nifedipine (Adalat, BAY A1040) and Candesartan (Atacand, BAY 12-9333) (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

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.

Clinical Details

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

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

Primary outcome:

Maximum drug concentration in plasma (Cmax) of nifedipine and candesartan

Area under the drug-concentration vs. time curve from time 0 to the last data point (AUC(0 tn)) of nifedipine and candesartan

Secondary outcome:

Area under the curve (AUC) of Nifedipine and Candesartan

Dose normalized Cmax (Cmax,norm) of Nifedipine and Candesartan

AUC normalized for dose and body weight (AUCnorm) of Nifedipine and Candesartan

Area under the plasma concentration-time curve from time zero to 48h (AUC(0-48))of Nifedipine and Candesartan

The time of the maximum concentration (Tmax) of Nifedipine and Candesartan

Half life (t1/2) of Nifedipine and Candesartan

The mean residence time (MRT) of Nifedipine and Candesartan

Oral plasma clearances (CL/F) of Nifedipine and Candesartan

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Male.

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

Locations and Contacts

Berlin 13353, Germany
Additional Information

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Starting date: April 2011
Last updated: July 13, 2015

Page last updated: August 23, 2015

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