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Bioavailability Of A Single Dose Of Nifedipine Oral Solution Compared To Adalat Capsules In Healthy Female Volunteers

NCT02071589 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2014-02-26

No results posted yet for this study

Summary

Phase I, crossover, randomised, single dose, relative bioavailability clinical trial of a new oral solution of nifedipine compared to Adalat soft gelatine capsules in healthy female volunteers.

Conditions

  • Bioequivalence

Interventions

DRUG

Nifedipine soft gelatine capsules

3 Adalat capsules of 10 mg each one

DRUG

Nifedipine oral solution

6 mL of Nife Par solution

Sponsors & Collaborators

  • Reig Jofre Group

    lead INDUSTRY

Principal Investigators

  • Rosa M Antonijoan, MD, PhD · CIM Sant Pau

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2009-03-31
Completion
2009-03-31

Countries

  • Spain

Study Locations

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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 NCT02071589 on ClinicalTrials.gov