Bioavailability Of A Single Dose Of Nifedipine Oral Solut... | NCT02071589

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

NCT02071589

Sponsor

Reig Jofre Group

Status

Completed

Last Update Posted

Feb 26, 2014Estimated

Enrollment

36Actual

Phase

Phase 1

Conditions

Bioequivalence

Interventions

Nifedipine soft gelatine capsules
Nifedipine oral solution

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
CIM/06/300/04	Other Identifier	CIM SANT PAU

Status Module

Record Verification Date

Feb 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

Mar 2009Actual

Completion Date

Mar 2009Actual

First Submitted Date

Dec 3, 2013

First Submission Date that Met QC Criteria

Feb 22, 2014

First Posted Date

Feb 26, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 22, 2014

Last Update Posted Date

Feb 26, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

36Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Nifedipine soft gelatine capsules	Drug	3 Adalat capsules of 10 mg each one	Nifedipine soft gelatine capsules

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D004095	Dihydropyridines
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds