MedTrace Logo

Nifedipine Bioavailability Study With Oral Single Doses Under Fasting and Fed Conditions

NCT00884442 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2009-10-21

No results posted yet for this study

Summary

The present study will be performed to investigate and to compare the in-vivo performance of the two investigational products Gen-nifedipine extended release, (previously referred to as Gen-Nifedipine XL (Genpharm ULC, Canada)) and Nifedipine(Bayer Healthcare AG manufactured as Adalat® XL®, Adalat® LA, Adalat® Crono, Adalat® OROS) by comparing their pharmacokinetic parameters after oral single dose administrations in the fasted and fed state.

Conditions

  • Bioavailability, Therapeutical Indication Not Studied

Interventions

DRUG

Nifedipine (Gen-nifedipine extended release, previously referred to as Gen-Nifedipine XL)

60 mg nifedipine

DRUG

Nifedipine (Bayer Healthcare AG manufactured as Adalat® XL®, Adalat® LA, Adalat® Crono, Adalat® OROS)

60 mg nifedipine

Sponsors & Collaborators

  • SocraMetrics GmbH

    collaborator INDUSTRY

  • SocraTec R&D GmbH

    lead OTHER

Principal Investigators

  • Frank Donath, MD · SocraTec R&D GmbH

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2009-04-30
Completion
2009-04-30

Countries

  • Germany

Study Locations

More Related Trials

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 NCT00884442 on ClinicalTrials.gov