Bioavailability study of the monosodium salt of (6S)-5-methyltetrahydrofolic acid compared to folic acid - a randomized, double-blind cross-over design study in healthy volunteers
- Conditions
- Healthy volunteers
- Registration Number
- DRKS00015783
- Lead Sponsor
- Merck & Cie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 24
Main inclusion criteria:
- Age: 18 - 50 years
- Healthy men and women
- BMI between 18 and 30 kg/m2 (boarders included)
- Nonsmoker
- Plasma folate between 7 – 45 nmol/L
- RBC folate between 405 – 952 nmol/L (Immulite 2000®, converted to be equivalent to 340 – 906 nmol/L according to WHO cutoffs)
Main exclusion criteria:
- Anemia (women Hb <12.0 g/dL; men Hb<13.0 g/dL) - Low vitamin B12 levels (<148 pmol/L)
- Homocysteine levels = 15.0 µmol/L
- Pregnancy and breastfeeding
- Intake of folate supplements during the last 3 months prior to study and during study
- Intake of supplements / drugs interfering with the study 2 months prior to study and during study (e.g. antacids, omeprazole, antifolate (MTX), vitamin C, biotin (>5 mg/day))
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparison of AUC0-8h between the two folates. The concentration of (6S)-5-methyltetrahydrofolate will be determined in plasma samples at pre, 15 min, 30 min, 60 min, 120 min, 180 min, 240 min, 360 min, 480 min. The pharmacokinetic parameters will be determined from the concentration-time curves.
- Secondary Outcome Measures
Name Time Method Comparison of the pharmacokinetic endpoints Cmax and Tmax between the two folates. <br>Additionally, for the parameters plasma total folate, non-methyltetrahydrofolate and unmetabolized folic acid the pharmacokinetic endpoints will be determined and compared between the two folates. <br>All pharmakokinetic endpoints will be determined from concentration-time curves, see above.