Therapeutic Equivalency, Healthy

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Condition / disease
Location
Status: Not yet recruiting

Bioequivalence Study of WP205 in Healthy Subjects

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.

Participants needed: 14
Trial details
Phase: Phase 1Age: 18+Biological sex: AllType: InterventionalSponsor: Wanbangde Pharmaceutical Group Co., LTDUpdated: Sep 5, 2025
Eligibility criteria

Subjects have been fully informed of the study purpose, nature, procedures, and... [+3]

Known allergy to methylconalamin injection, methylconalamin injection, or any co... [+19]