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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

NCT01227603 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2015-12-10

No results posted yet for this study

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

Conditions

  • Hypertension, Essential

Interventions

DRUG

Nifedipine-candesartan FDC (BAY 98-7106)

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

DRUG

Nifedipine GITS (Adalat LA, BAYA1040)

Single oral dose of 1 tablet of nifedipine GITS 60 mg

DRUG

Candesartan (Atacand)

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

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2011-03-31
Completion
2011-07-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01227603 on ClinicalTrials.gov