Bioavailability Of A Single Dose Of Nifedipine Oral Solution Compared To Adalat Capsules In Healthy Female Volunteers (NIFEPAR_PK1)

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

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.

Study Overview

• Status: Completed
• Conditions: Bioequivalence
• Intervention / Treatment: Drug: Nifedipine oral solution; Drug: Nifedipine soft gelatine capsules

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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08025
    • CIM Sant Pau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Women aged 18 to 45.
• Body weight within the normal range (Quetelet index between 19 and 26) expressed as weight (kg) / height (m2) .
• Medical history , physical examination within normal appliances .
• No evidence of significant organic or psychiatric disease based on history, physical examination and laboratory tests .
• Laboratory tests (hematology and biochemistry) within the normal range , according to normal reference values of the Biochemistry laboratory of Hospital de la Santa Creu i Sant Pau. Variations may be allowed based on clinical judgment of the Centre d' Investigacio Medicament (CIM ) .
• Vital signs: blood pressure (Systolic Blood Pressure (SBP) > 90 <140 mm Hg / Diastolic Blood Pressure (DBP) > 50 <90 mm Hg ), heart rate (> 50 <90 ) , temperature and ECG record within normal range.
• Not having participated in another clinical trial during the previous three months at the beginning of the current study .
• Not having donated blood in the previous four weeks.
• Free acceptance to participate in the trial. Written informed consent signed.
• Use of effective contraception different from oral contraceptives.

Exclusion Criteria:

• Previous history of alcohol or drug use or abuse during the previous month to the selection process.
• High consumption of stimulant beverages (> 5 coffee, tea, cola drinks daily).
• Previous history of allergy, drug hypersensitivity or idiosyncrasy.
• Taking any medication in the 4 weeks preceding the trial, including non-prescription medicines and herbal remedies.
• Positive serology for hepatitis B, C or HIV.
• History or clinical evidence of cardiovascular disease, respiratory, renal, hepatic, endocrine, gastrointestinal, hematological, neurological or other chronic diseases.
• Having had surgery during the previous 6 months.
• Having donated blood in the month before the study began.
• Smokers.
• Positive pregnancy test at any monitoring during the study.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nifedipine oral solution; Nifedipine 5 mg/mL oral solution, 6 mL (30 mg of Nifedipine) at single dose	Drug: Nifedipine oral solution; 6 mL of Nife Par solution; Other Names: Nife-Par
Active Comparator: Nifedipine soft gelatine capsules; Nifedipine soft gelatine capsules x3 (total 30 mg Nifedipine) at a single dose	Drug: Nifedipine soft gelatine capsules; 3 Adalat capsules of 10 mg each one; Other Names: Adalat

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to maximal plasmatic concentrations, Tmax	pre-dose and +10', +20', +30', +45', +1h, +1h15', +1h30', +2h, +3h, +5h, +7h, +9h, +12h y +24h post dose

Collaborators and Investigators

• Sponsor: Reig Jofre Group
• Investigators: Principal Investigator: Rosa M Antonijoan, MD, PhD, CIM Sant Pau

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): March 1, 2009

Study Registration Dates

• First Submitted: December 3, 2013
• First Submitted That Met QC Criteria: February 22, 2014
• First Posted (Estimate): February 26, 2014

Study Record Updates

• Last Update Posted (Estimate): February 26, 2014
• Last Update Submitted That Met QC Criteria: February 22, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Reproductive Control Agents; Calcium Channel Blockers; Tocolytic Agents; Nifedipine
• Other Study ID Numbers: 2006-006159-11; CIM/06/300/04 (Other Identifier: CIM SANT PAU)