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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

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 (BAY98-7106) (Drug); Nifedipine (Adalat, BAYA1040) + Candesartan (Drug); Nifedipine (Adalat, BAYA1040) (Drug); Candesartan (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, 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

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

Primary outcome:

C(max) and AUC(0-tn) for nifedipine

C(max) and AUC(0-tn) for candesartan

Secondary outcome: Further pharmakokinetic parameters (AUC, C(max,norm), AUCnorm, AUC(0-48), tmax and t1/2) for nifedipine and candesartan

Eligibility

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

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 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

Locations and Contacts

Köln, Nordrhein-Westfalen 51063, Germany
Additional Information

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Starting date: November 2010
Last updated: May 12, 2015

Page last updated: August 23, 2015

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