Clinical trial NCT02071589: Bioavailability Of A Single Dose Of Nifedipine Oral Solution Compared To Adalat Capsules In Healthy Female Volunteers
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bioequivalence
Lead sponsor: Reig Jofre Group
Sponsor class: INDUSTRY
First posted: 2014-02-26
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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.

Eligibility 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.

Primary outcomes:
measure: Area Under the Concentration-Time Curve (AUC 0-24h)
timeFrame: pre-dose and +10', +20', +30', +45', +1h, +1h15', +1h30', +2h, +3h, +5h, +7h, +9h, +12h y +24h post dose
measure: Maximal plasmatic concentrations, Cmax
timeFrame: pre-dose and +10', +20', +30', +45', +1h, +1h15', +1h30', +2h, +3h, +5h, +7h, +9h, +12h y +24h post dose
Secondary outcomes:
measure: Time to maximal plasmatic concentrations, Tmax
timeFrame: pre-dose and +10', +20', +30', +45', +1h, +1h15', +1h30', +2h, +3h, +5h, +7h, +9h, +12h y +24h post dose
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: CIM Sant Pau
Study officials:
affiliation: CIM Sant Pau
name: Rosa M Antonijoan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: