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Trial record 13 of 143 for:    NIFEDIPINE

Bioavailability Of A Single Dose Of Nifedipine Oral Solution Compared To Adalat Capsules In Healthy Female Volunteers (NIFEPAR_PK1)

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ClinicalTrials.gov Identifier: NCT02071589
Recruitment Status : Completed
First Posted : February 26, 2014
Last Update Posted : February 26, 2014
Sponsor:
Information provided by (Responsible Party):
Reig Jofre Group

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.

Condition or disease Intervention/treatment Phase
Bioequivalence Drug: Nifedipine soft gelatine capsules Drug: Nifedipine oral solution Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: 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
Study Start Date : January 2009
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

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Arm Intervention/treatment
Experimental: Nifedipine oral solution
Nifedipine 5 mg/mL oral solution, 6 mL (30 mg of Nifedipine) at single dose
Drug: Nifedipine oral solution
6 mL of Nife Par solution
Other Name: Nife-Par

Active Comparator: Nifedipine soft gelatine capsules
Nifedipine soft gelatine capsules x3 (total 30 mg Nifedipine) at a single dose
Drug: Nifedipine soft gelatine capsules
3 Adalat capsules of 10 mg each one
Other Name: Adalat




Primary Outcome Measures :
  1. Area Under the Concentration-Time Curve (AUC 0-24h) [ Time Frame: pre-dose and +10', +20', +30', +45', +1h, +1h15', +1h30', +2h, +3h, +5h, +7h, +9h, +12h y +24h post dose ]
  2. Maximal plasmatic concentrations, Cmax [ Time Frame: pre-dose and +10', +20', +30', +45', +1h, +1h15', +1h30', +2h, +3h, +5h, +7h, +9h, +12h y +24h post dose ]

Secondary Outcome Measures :
  1. Time to maximal plasmatic concentrations, Tmax [ Time Frame: pre-dose and +10', +20', +30', +45', +1h, +1h15', +1h30', +2h, +3h, +5h, +7h, +9h, +12h y +24h post dose ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02071589


Locations
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Spain
CIM Sant Pau
Barcelona, Spain, 08025
Sponsors and Collaborators
Reig Jofre Group
Investigators
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Principal Investigator: Rosa M Antonijoan, MD, PhD CIM Sant Pau

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Responsible Party: Reig Jofre Group
ClinicalTrials.gov Identifier: NCT02071589     History of Changes
Other Study ID Numbers: 2006-006159-11
CIM/06/300/04 ( Other Identifier: CIM SANT PAU )
First Posted: February 26, 2014    Key Record Dates
Last Update Posted: February 26, 2014
Last Verified: February 2014
Additional relevant MeSH terms:
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Nifedipine
Pharmaceutical Solutions
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Tocolytic Agents
Reproductive Control Agents