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

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Reig Jofre Group
• Treatments: Nifedipine; Pharmaceutical Solutions

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.