NCT07158099

Bioequivalence Study of WP205 in Healthy Subjects

A Single-Center, Randomized, Open-Label, Two-Period, Two-Sequence, Single-Dose, Crossover Bioequivalence Study of Methylconalamin Injection and Methylconalamin for Injection in Healthy Subjects Under Fasting Conditions

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (estimated)
• Sponsor: Wanbangde Pharmaceutical Group Co., LTD · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study is a single-center, randomized, open-label, two-period, two-sequence, single-dose, crossover bioequivalence trial conducted under fasting conditions in healthy adult volunteers. Participants will be randomized into two sequences (A and B). Each participant will receive a single intramuscular dose of the test or reference formulation according to the assigned sequence, with an adequate washout period between dosing. The primary objective of the study is to evaluate the bioequivalence of the two formulations.

Conditions

• Therapeutic Equivalency, Healthy

Interventions

Type	Name	Description
DRUG	Methylconalamin Injection(WP205)	25 mg intramuscular injection in the upper-arm deltoid
DRUG	Methylconalamin for Injection	25 mg intramuscular injection in the upper-arm deltoid

Timeline

• Start date: 2025-09-15
• Primary completion: 2025-09-30
• Completion: 2025-09-30
• First posted: 2025-09-05
• Last updated: 2025-09-05