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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental |
| |
| Group B | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylconalamin Injection(WP205) | Drug | 25 mg intramuscular injection in the upper-arm deltoid |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) | 0 to 24 hours after each single intramuscular dose | |
| Area under the plasma concentration versus time curve (AUC)0-t | 0 to 24 hours after each single intramuscular dose | |
| Area under the plasma concentration versus time curve (AUC)0-∞ | 0 to 24 hours after each single intramuscular dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Provincial People's Hospital | Hangzhou | Zhejiang | China |
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| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| Methylconalamin for Injection | Drug | 25 mg intramuscular injection in the upper-arm deltoid |
|