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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02071589

Acronym

NIFEPAR_PK1

Enrollment

Registered

2014-02-26

Start date

2009-01-31

Completion date

2009-03-31

Last updated

2014-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bioequivalence

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.

Interventions

DRUGNifedipine soft gelatine capsules

3 Adalat capsules of 10 mg each one

DRUGNifedipine oral solution

6 mL of Nife Par solution

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	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

Measure	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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026