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
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.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Female.
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.
Locations and Contacts
CIM Sant Pau, Barcelona 08025, Spain
Additional Information
Starting date: January 2009
Last updated: February 22, 2014
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