HealthyPhase 1NCT00709267
Bioavailability Study of Folic Acid in Healthy Women
A Phase 1 study testing Folic acid in people with Healthy and Pharmacokinetics, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial summary
The purpose of the study is to determine the bioavailability of orally administered folic acid compared with the i.v. administered folic acid, and to use the samples collected to validate the analytical methods for estimation of folic acid in plasma and red blood cells (RBCs). 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
- Healthy, Pharmacokinetics
- What is being tested?
- Folic acid
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Oct 2004to Dec 2004
- 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
- Healthy
- Nonpregnant
- Nonlactating
- Nonsmoking women
- With a history of regular menstrual cycles
- Weighing at least 110 pounds
- Having a body mass index between 18 and 28 kg/m2
- And having a hematocrit of at least 36%
Who cannot join
- Known history of vitamin B-12 deficiency or a current need for vitamin B-12 injections
- Elevated blood pressure (BP) (i.e., sitting systolic BP >140 mm mercury [Hg] and/or diastolic BP >90 mm Hg)
- Had tested positive for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (anti-HCV)
- Recent history (within 12 months prior to the first admission visit) of alcohol or other substance abuse or tested positive for drugs of abuse, such as amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, and tricyclic antidepressant agents
- Used barbiturates, antiepileptics, rifampin, griseofulvin, St. John's Wort or other hepatic enzyme inducing drugs within 30 days before randomization
About this study
Official title: A Randomized, Open Label Absolute Bioavailability Study of Folic Acid.
The purpose of the study is to determine the bioavailability of orally administered folic acid compared with the i.v. administered folic acid, and to use the samples collected to validate the analytical methods for estimation of folic acid in plasma and red blood cells (RBCs).
Read the detailed description
Few formal pharmacokinetic studies have been conducted with folic acid to determine its absolute bioavailability, pharmacokinetic profile, or intra- and intersubject variability. Moreover, most analytical work has been completed in academic settings, and no Good Laboratory Practice (GLP)-validated assay method has been developed. This was a randomized (study drug assigned by chance), open-label, 3-way crossover, single-center trial, consisting of a prerandomization phase, an open-label treatment phase (3 single doses separated by washouts of 7 days each), and a posttreatment phase. Healthy volunteers were randomly assigned to 1 of 6 treatment sequences (2 healthy volunteers per sequence). All healthy volunteers received a single dose of folic acid in each treatment period (400-mcg oral solution, 400-mcg i.v. infusion, and a 1-mg oral tablet). Blood samples for pharmacokinetic analysis were collected at specified times following each dose. Blood samples for measurement of red cell folate were collected before dosing on Day 1 of Period 1. For each period, healthy volunteers were confined to the study unit from the evening before Day 1 through the completion of the Day 2 assessments (24-hour pharmacokinetic blood sample collection). End-of-study assessments took place on Day 17 or at the time of early withdrawal. Safety was evaluated based on the monitoring of adverse events, vital sign measurements, physical examinations, and clinical laboratory tests. Heart rate and blood pressure were measured at screening, on the first day of each treatment period (Days 1, 8, and 15), and at study completion (Day 17) or early withdrawal; body temperature was measured at screening only. A physical examination was performed at screening and at study completion (Day 17) or early withdrawal. Blood samples for serum chemistry and hematology and a random urine sample for urinalysis were taken at the start of the study, Days -21 to -2, and at the end of the study (Day 17 or early termination).
All subjects received a single dose of folic acid in each treatment period (400-mcg oral solution, 400-mcg i.v. infusion, and a 1-mg oral tablet), separated by washouts of 7 days each.
- Conditions
- Healthy, Pharmacokinetics
- Being tested
- Folic acid
- Keywords
- Folic Acid, Chemistry, Analytical, Administration, Oral, Infusions, Intravenous, Biological Availability, Safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Folic acidDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the absolute bioavailability of orally administered folic acid; Estimate intrasubject variance; Validate analytical methods to determine the folate levels in plasma and RBCs
Secondary outcomes (1)
Assessment of safety
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2008 (estimated)
- Study startOct 2004
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00709267
- Sponsor's protocol ID
- CR002386
- Status last verified
- Apr 2010
- First submitted
- 30 Jun 2008
- Last updated
- 8 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label Absolute Bioavailability Study of Folic Acid.
- ClinicalTrials.gov ID
- NCT00709267
- Acronym / sponsor ID
- CR002386
- Conditions
- Healthy, Pharmacokinetics
- Keywords
- Folic Acid, Chemistry, Analytical, Administration, Oral, Infusions, Intravenous, Biological Availability, Safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- Oct 2004
- Study completion
- Dec 2004 (actual)
- First posted
- 3 Jul 2008 (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.
The purpose of the study is to determine the bioavailability of orally administered folic acid compared with the i.v. administered folic acid, and to use the samples collected to validate the analytical methods for estimation of folic acid in plasma and red blood cells (RBCs).
Detailed description
Few formal pharmacokinetic studies have been conducted with folic acid to determine its absolute bioavailability, pharmacokinetic profile, or intra- and intersubject variability. Moreover, most analytical work has been completed in academic settings, and no Good Laboratory Practice (GLP)-validated assay method has been developed. This was a randomized (study drug assigned by chance), open-label, 3-way crossover, single-center trial, consisting of a prerandomization phase, an open-label treatment phase (3 single doses separated by washouts of 7 days each), and a posttreatment phase. Healthy volunteers were randomly assigned to 1 of 6 treatment sequences (2 healthy volunteers per sequence). All healthy volunteers received a single dose of folic acid in each treatment period (400-mcg oral solution, 400-mcg i.v. infusion, and a 1-mg oral tablet). Blood samples for pharmacokinetic analysis were collected at specified times following each dose. Blood samples for measurement of red cell folate were collected before dosing on Day 1 of Period 1. For each period, healthy volunteers were confined to the study unit from the evening before Day 1 through the completion of the Day 2 assessments (24-hour pharmacokinetic blood sample collection). End-of-study assessments took place on Day 17 or at the time of early withdrawal. Safety was evaluated based on the monitoring of adverse events, vital sign measurements, physical examinations, and clinical laboratory tests. Heart rate and blood pressure were measured at screening, on the first day of each treatment period (Days 1, 8, and 15), and at study completion (Day 17) or early withdrawal; body temperature was measured at screening only. A physical examination was performed at screening and at study completion (Day 17) or early withdrawal. Blood samples for serum chemistry and hematology and a random urine sample for urinalysis were taken at the start of the study, Days -21 to -2, and at the end of the study (Day 17 or early termination).
All subjects received a single dose of folic acid in each treatment period (400-mcg oral solution, 400-mcg i.v. infusion, and a 1-mg oral tablet), separated by washouts of 7 days each.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy
- Nonpregnant
- Nonlactating
- Nonsmoking women
- With a history of regular menstrual cycles
Key exclusion criteria (5 listed)
- Known history of vitamin B-12 deficiency or a current need for vitamin B-12 injections
- Elevated blood pressure (BP) (i.e., sitting systolic BP >140 mm mercury [Hg] and/or diastolic BP >90 mm Hg)
- Had tested positive for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (anti-HCV)
- Recent history (within 12 months prior to the first admission visit) of alcohol or other substance abuse or tested positive for drugs of abuse, such as amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, and tricyclic antidepressant agents
- Used barbiturates, antiepileptics, rifampin, griseofulvin, St. John's Wort or other hepatic enzyme inducing drugs within 30 days before randomization
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 |
|---|---|---|
| Folic acid | Drug | – |
Primary outcome
Determine the absolute bioavailability of orally administered folic acid; Estimate intrasubject variance; Validate analytical methods to determine the folate levels in plasma and RBCs
1 secondary outcome
Assessment of safety
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 8 Jun 2011.
- Bioavailability study of folic acid in healthy womenLink provided by the sponsor.
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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.
Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Folic acid in people with Healthy and Pharmacokinetics, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
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 8 inclusion and 5 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 8 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
Determine the absolute bioavailability of orally administered folic acid; Estimate intrasubject variance; Validate analytical methods to determine the folate levels in plasma and RBCs. 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 8 Jun 2011.