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Bioequivalence Study of WP205 in Healthy Participants

NCT07281872 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-12-15

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Wanbangde Pharmaceutical Group Co., LTD

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-10-29
Primary Completion
2025-11-06
Completion
2028-11-25

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07281872 on ClinicalTrials.gov