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 (NIFEPAR_PK1)

NCT02071589 Phase 1 COMPLETED

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.

Details

Lead sponsor	Reig Jofre Group
Phase	Phase 1
Status	COMPLETED
Enrolment	36
Start date	2009-01
Completion	2009-03

Conditions

• Bioequivalence

Interventions

• Nifedipine soft gelatine capsules
• Nifedipine oral solution

Primary outcomes

• Area Under the Concentration-Time Curve (AUC 0-24h) — pre-dose and +10', +20', +30', +45', +1h, +1h15', +1h30', +2h, +3h, +5h, +7h, +9h, +12h y +24h post dose
• Maximal plasmatic concentrations, Cmax — pre-dose and +10', +20', +30', +45', +1h, +1h15', +1h30', +2h, +3h, +5h, +7h, +9h, +12h y +24h post dose

Countries

Spain