BioequivalencePhase 1NIFEPAR_PK1NCT02071589
Bioavailability Of A Single Dose Of Nifedipine Oral Solution Compared To Adalat Capsules In Healthy Female Volunteers
A Phase 1 study testing Nifedipine soft gelatine capsules and Nifedipine oral solution in people with Bioequivalence, run by Reig Jofre Group at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bioequivalence
- What is being tested?
- Nifedipine soft gelatine capsules and Nifedipine oral solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2009to Mar 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Bioequivalence
- Being tested
- Nifedipine soft gelatine capsules, Nifedipine oral solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nifedipine soft gelatine capsulesDrug
Also called Adalat
3 Adalat capsules of 10 mg each one
Nifedipine oral solutionDrug
Also called Nife-Par
6 mL of Nife Par solution
| Study group | Role | What they receive |
|---|---|---|
| Nifedipine oral solution | Experimental | Nifedipine 5 mg/mL oral solution, 6 mL (30 mg of Nifedipine) at single dose Receives: Drug: Nifedipine oral solution |
| Nifedipine soft gelatine capsules | Active comparator | Nifedipine soft gelatine capsules x3 (total 30 mg Nifedipine) at a single dose Receives: Drug: Nifedipine soft gelatine capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Concentration-Time Curve (AUC 0-24h)
Measured: pre-dose and +10', +20', +30', +45', +1h, +1h15', +1h30', +2h, +3h, +5h, +7h, +9h, +12h y +24h post dose
Maximal plasmatic concentrations, Cmax
Measured: 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
Measured: pre-dose and +10', +20', +30', +45', +1h, +1h15', +1h30', +2h, +3h, +5h, +7h, +9h, +12h y +24h post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2014 (estimated)
- Study startJan 2009
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BioequivalenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reig Jofre Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rosa M Antonijoan, MD, PhD, Principal investigator, CIM Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02071589
- Sponsor's protocol ID
- 2006-006159-11
- Other IDs
- CIM/06/300/04
- Acronym
- NIFEPAR_PK1
- Status last verified
- Feb 2014
- First submitted
- 3 Dec 2013
- Last updated
- 26 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02071589
- Acronym / sponsor ID
- NIFEPAR_PK1 / 2006-006159-11
- Conditions
- Bioequivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Reig Jofre GroupIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 26 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nifedipine oral solution | Experimental | Drug: Nifedipine oral solutionNifedipine 5 mg/mL oral solution, 6 mL (30 mg of Nifedipine) at single dose |
| Nifedipine soft gelatine capsules | Active comparator | Drug: Nifedipine soft gelatine capsulesNifedipine soft gelatine capsules x3 (total 30 mg Nifedipine) at a single dose |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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 ) .
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nifedipine soft gelatine capsulesAlso: Adalat3 Adalat capsules of 10 mg each one | Drug | Nifedipine soft gelatine capsules |
| Nifedipine oral solutionAlso: Nife-Par6 mL of Nife Par solution | Drug | Nifedipine oral solution |
Primary outcome
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
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosa M Antonijoan, MD, PhD principal investigator
CIM Sant Pau
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nifedipine soft gelatine capsules and Nifedipine oral solution in people with Bioequivalence, run by Reig Jofre Group at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2014.