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

Bioequivalence Clinical Trial

— NIFEPAR_PK1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02071589
• Other study ID #: 2006-006159-11
• Secondary ID: CIM/06/300/04
• Status: Completed
• Phase: Phase 1
• First received: December 3, 2013
• Last updated: February 22, 2014
• Start date: January 2009
• Est. completion date: March 2009

Study information

• Verified date: February 2014
• Source: Reig Jofre Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Bioequivalence

Intervention

Drug:
• Nifedipine soft gelatine capsules
3 Adalat capsules of 10 mg each one
• Nifedipine oral solution
6 mL of Nife Par solution

Locations

Country	Name	City	State
Spain	CIM Sant Pau	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Reig Jofre Group

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Maximal plasmatic concentrations, Cmax		pre-dose and +10', +20', +30', +45', +1h, +1h15', +1h30', +2h, +3h, +5h, +7h, +9h, +12h y +24h post dose	No
Secondary	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	No