Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2025-12-29 @ 4:46 PM
Study NCT ID:
NCT00709267
Status:
COMPLETED
Last Update Posted:
2011-06-08
First Post:
2008-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioavailability Study of Folic Acid in Healthy Women
Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Organization:
Study Overview
Official Title:
A Randomized, Open Label Absolute Bioavailability Study of Folic Acid.
Status:
COMPLETED
Status Verified Date:
2010-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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).
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.
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: