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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-03-31

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.

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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.

Conditions

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Bioequivalence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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Nifedipine oral solution

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

Group Type EXPERIMENTAL

Nifedipine oral solution

Intervention Type DRUG

6 mL of Nife Par solution

Nifedipine soft gelatine capsules

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

Group Type ACTIVE_COMPARATOR

Nifedipine soft gelatine capsules

Intervention Type DRUG

3 Adalat capsules of 10 mg each one

Interventions

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Nifedipine soft gelatine capsules

3 Adalat capsules of 10 mg each one

Intervention Type DRUG

Nifedipine oral solution

6 mL of Nife Par solution

Intervention Type DRUG

Other Intervention Names

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Adalat Nife-Par

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes