Healthy subjects
Conditions
Interventions
Group 1: Folic acid, 400 µg, single dose oral, 1 capsule
Group 2: Dicholine L-methylfolate, equimolar with 400 µg folic acid
Sponsors
Aprofol AG
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: - 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);
Exclusion criteria
Exclusion criteria: Main exclusion criteria: - Anemia (women Hb 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.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - 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
| Measure | Time frame |
|---|---|
| - Comparison of iAUC 0-24h between formulations. - Comparison of the pharmacokinetic parameters Cmax, Tmax. 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. The characteristics are calculated from the plasma concentration-time curves, see above. | — |
Countries
Germany
Contacts
Public ContactDaniel Menzel
BioTeSys GmbH
Outcome results
None listed