Bioequivalence Study of WP205 in Healthy Participants

What Was Tested

The trial (phase 1) is built around Cyanocobalamin (Vitamin B12).

Participants will be randomized into two sequences (A and B).

It had two arms (groups): one (experimental) and one (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 20 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Male or female subjects aged 18 years or older, with an appropriate gender distribution. Body weight: females ≥ 45.0 kg, males ≥ 50.0 kg, and body mass index (BMI) between 19.0 and 26.0 kg/m² (inclusive); BMI = weight (kg) / height² (m²).

The full record lists 4 inclusion and 20 exclusion criteria; among the exclusions: known allergy to methylcobalamin injection, methylcobalamin injection, or any component of the formulations, or history of hypersensitivity (e.g., rash, urticaria); smoking ≥5 cigarettes/day within 3 months prior to screening, or inability to stop tobacco use during the study, or positive nicotine test; history of substance abuse within 3 months prior to screening, or positive drug screening.

How the Study Was Run

The set-up was randomized, crossover and open-label.

Random assignment meant chance, not the researchers, decided who got Cyanocobalamin (Vitamin B12) and who got the comparison, which limits bias.

In the crossover set-up each of the participants took both Cyanocobalamin (Vitamin B12) and the comparison in turn, acting as their own control.

Nothing was hidden in this open-label Cyanocobalamin (Vitamin B12) study: the participants and staff both knew the treatment.

It started in 2025-10-29 with completion listed for 2025-11-06.

It ran at 1 site in China.

Its stated primary purpose is other.

What Was Measured

Researchers chose this as the main measure: Peak Plasma Concentration (Cmax). Area under the plasma concentration versus time curve (AUC)0-t. Area under the plasma concentration versus time curve (AUC)0-∞.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Cyanocobalamin (Vitamin B12) in 20 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Cyanocobalamin (Vitamin B12) compound page, all human trials.