NCT02071589

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

Crossover Randomised Bioavailability Clinical Study Of A Single Dose Of Nifedipine Oral Solution From Laboratorio Reig Jofre S.A. Compared To Adalat(R) Capsules In Healthy Female Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Reig Jofre Group · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

The study was designed to compare the bioavailability of nifedipine new formulation specially designed to be used in pre-term labour management instead of anti-hypertensive therapy.

Conditions

• Bioequivalence

Interventions

Type	Name	Description
DRUG	Nifedipine soft gelatine capsules	3 Adalat capsules of 10 mg each one
DRUG	Nifedipine oral solution	6 mL of Nife Par solution

Timeline

• Start date: 2009-01-01
• Primary completion: 2009-03-01
• Completion: 2009-03-01
• First posted: 2014-02-26
• Last updated: 2014-02-26

Locations

1 site across 1 country: Spain