Trial | NCT02071589  Report issue

Title

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

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    nifedipine ...

  • Study Participants

    36
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.
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 Started
Jan 31
2009
Primary Completion
Mar 31
2009
Study Completion
Mar 31
2009
Last Update
Feb 26
2014
Estimate

Drug Nifedipine soft gelatine capsules

3 Adalat capsules of 10 mg each one

  • Other names: Adalat

Drug Nifedipine oral solution

6 mL of Nife Par solution

  • Other names: Nife-Par

Nifedipine oral solution Experimental

Nifedipine 5 mg/mL oral solution, 6 mL (30 mg of Nifedipine) at single dose

Nifedipine soft gelatine capsules Active Comparator

Nifedipine soft gelatine capsules x3 (total 30 mg Nifedipine) at a single dose

Criteria 

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.
No Results Posted