Bioavailability Of A Single Dose Of Nifedipine Oral Solution Compared To Adalat Capsules In Healthy Female Volunteers
Phase 1
Completed
- Conditions
- Bioequivalence
- Interventions
- Registration Number
- NCT02071589
- Lead Sponsor
- Reig Jofre Group
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 36
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
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Nifedipine oral solution Nifedipine oral solution Nifedipine 5 mg/mL oral solution, 6 mL (30 mg of Nifedipine) at single dose Nifedipine soft gelatine capsules Nifedipine soft gelatine capsules Nifedipine soft gelatine capsules x3 (total 30 mg Nifedipine) at a single dose
- Primary Outcome Measures
Name Time Method 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 Maximal plasmatic concentrations, Cmax pre-dose and +10', +20', +30', +45', +1h, +1h15', +1h30', +2h, +3h, +5h, +7h, +9h, +12h y +24h post dose
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
CIM Sant Pau
🇪🇸Barcelona, Spain