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

Information source: Reig Jofre Group
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bioequivalence

Intervention: Nifedipine soft gelatine capsules (Drug); Nifedipine oral solution (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Reig Jofre Group

Official(s) and/or principal investigator(s):
Rosa M Antonijoan, MD, PhD, Principal Investigator, Affiliation: CIM Sant Pau


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.

Clinical Details

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

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

Primary outcome:

Area Under the Concentration-Time Curve (AUC 0-24h)

Maximal plasmatic concentrations, Cmax

Secondary outcome: Time to maximal plasmatic concentrations, Tmax

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.


Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Female.


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.

Locations and Contacts

CIM Sant Pau, Barcelona 08025, Spain
Additional Information

Starting date: January 2009
Last updated: February 22, 2014

Page last updated: August 23, 2015

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