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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Bioequivalence

Intervention / Treatment
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* Drug: Nifedipine soft gelatine capsules
* Drug: Nifedipine oral solution


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nifedipine oral solution<br>Nifedipine 5 mg/mL oral solution, 6 mL (30 mg of Nifedipine) at single dose | Drug: Nifedipine oral solution<br>* 6 mL of Nife Par solution<br>* Other names: Nife-Par;|
| Active Comparator: Nifedipine soft gelatine capsules<br>Nifedipine soft gelatine capsules x3 (total 30 mg Nifedipine) at a single dose | Drug: Nifedipine soft gelatine capsules<br>* 3 Adalat capsules of 10 mg each one<br>* Other names: Adalat;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |