Status:
COMPLETED
Bioavailability Study of Folic Acid in Healthy Women
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Healthy
Pharmacokinetics
Eligibility:
FEMALE
18-45 years
Phase:
PHASE1
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 analytic...
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 analyt...
Eligibility Criteria
Inclusion
- 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%
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2004
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00709267
Start Date
October 1 2004
End Date
December 1 2004
Last Update
June 8 2011
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