NCT02071589

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2009

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

December 3, 2013

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 26, 2014

Completed
Last Updated

February 26, 2014

Status Verified

February 1, 2014

Enrollment Period

2 months

First QC Date

December 3, 2013

Last Update Submit

February 22, 2014

Conditions

Bioequivalence

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • 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

Study Arms (2)

Nifedipine oral solution

EXPERIMENTAL

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

Drug: Nifedipine oral solution

Nifedipine soft gelatine capsules

ACTIVE COMPARATOR

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

Drug: Nifedipine soft gelatine capsules

Interventions

Nifedipine soft gelatine capsulesDRUG

3 Adalat capsules of 10 mg each one

Also known as: Adalat
Nifedipine soft gelatine capsules
Nifedipine oral solutionDRUG

6 mL of Nife Par solution

Also known as: Nife-Par
Nifedipine oral solution

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CIM Sant Pau

Barcelona, Barcelona, 08025, Spain

Location

MeSH Terms

Interventions

Nifedipine

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Rosa M Antonijoan, MD, PhD

    CIM Sant Pau

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2013

First Posted

February 26, 2014

Study Start

January 1, 2009

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

February 26, 2014

Record last verified: 2014-02

Locations

ES(1)