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

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 - BTS1248/18

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00015783

Enrollment

Registered

2018-10-29

Start date

2018-11-19

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy volunteers

Interventions

Group 1: Folic acid, 400 µg, single dose oral, 1 capsule Group 2: Monosodium salt of (6S)-5-methyltetrahydrofolic acid, equimolar to 400 µg folic acid

single dose oral, 1 capsule

Eligibility

Sex/Gender

All

Age

18 Years to 50 Years

Inclusion criteria

Inclusion criteria: 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)

Exclusion criteria

Exclusion criteria: Main exclusion criteria: - Anemia (women Hb 5 mg/day))

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Comparison of the pharmacokinetic endpoints Cmax and Tmax between the two folates. 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. All pharmakokinetic endpoints will be determined from concentration-time curves, see above.	—

Countries

Germany

Contacts

Public ContactTanita Dharsono

BioTeSys GmbH

o.studie@biotesys.de+49 711 351 38 35

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026