Pharmacokinetic of a new folate salt compared to folic acid: a randomized cross-over study with healthy subjects
- Conditions
- Healthy subjects
- Registration Number
- DRKS00032494
- Lead Sponsor
- Aprofol AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 24
Healthy men and women (12 of each gender)
- BMI between 19 and 30 kg/m2 (boarders included)
- Subject is able and willing to sign the Informed Consent Form prior to screening evaluations
- Subject is in good physical and mental health as established by medical history, physical examination, ECG, vital signs, results of biochemistry, hematology
- For women: Non-menopausal with the same reliable contraception since at least three months before the beginning of the study (Screening) and agreeing to keep it during the entire duration of the study (abstinence, hormonal contraception, intra uterine device or surgical intervention) or menopausal with or without hormone replacement therapy (estrogenic replacement therapy begun from less than 3 months before Screening excluded);
Main exclusion criteria:
- Anemia (women Hb <12.0 g/dL; men Hb <13.0 g/dL)
- Plasma homocysteine concentrations = 18.0 µmol/L that could indicate either folate or vitamin B12 deficiency
- Smoker
- Regular intake of folate supplements containing at least 200 µg folate in the 3 months prior to the study
- Taking any supplements containing folate during the study
- Regular intake of drugs or supplements possibly interfering with this study in the last 2 months prior to the study and during the study (e.g. antifolate (MTX), vitamin C, or biotin (>5 mg/day), antidepressents e.g. selective serotonin reuptake inhibitors (SSRIs))
- Regular intake of medications that interfere with the gastrointestinal pH such as antacids and omeprazole.
- Intake of medications or plant extracts that interfere with the gastrointestinal emptying such as e.g. metoclopramide (reglan), motilium, movicol, laxatives, erythromycin, and antispasmodics.
- Intakes of antibiotics within last 4 weeks, regular use of non-steroidal anti-inflammatory drugs (i.e. ibuprofen, diclofenac), and aspirin.
- Intake of fat- or carbohydrate adsorbents for weight control.
- Subjects with history of atrophic gastritis, H. pylori infection, bariatric surgery, pernicious anemia, or recurrent diarrhea.
- To exclude possible low B12 status, people who adhere to a vegan diet for = 1 year or to a vegetarian diet or avoidance of eating meat for = 5 years.
- History of severe medical disorders, that may affect folate bioavailability (e.g. malabsorption, chronic gastro-intestinal diseases, depression, diabetes (type 1 and type 2), current cancer except basal cell carcinoma of the skin within last 3 years, etc.)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - Comparison of iAUC0-8h (incremental area under the cruve) between the two forms. Total folate is determined in the plasma samples at the time points pre, 15 min, 30 min, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours. The pharmacokinetic characteristics are determined from the concentration-time curves.
- Secondary Outcome Measures
Name Time Method - Comparison of iAUC 0-24h between formulations.<br>- Comparison of the pharmacokinetic parameters Cmax, Tmax. <br>In addition, the pharmacokinetic endpoints for the parameters (6S)-5-methyltetrahydrofolate, non-methyltetrahydrofolate and non-metabolised folic acid are determined and compared between the two folates. <br>The characteristics are calculated from the plasma concentration-time curves, see above.