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

Reig Jofre

Status and phase

Completed

Phase 1

Conditions

Bioequivalence

Treatments

Drug: Nifedipine oral solution

Drug: Nifedipine soft gelatine capsules

Study type

Interventional

Funder types

Industry

Identifiers

NCT02071589

2006-006159-11

CIM/06/300/04 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

36 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.