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Bioequivalence Study of WP205 in Healthy Subjects

ConditionTherapeutic Equivalency, Healthy
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorWanbangde Pharmaceutical Group Co., LTD

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Subjects have been fully informed of the study purpose, nature, procedures, and potential adverse reactions, voluntarily agree to participate, and have signed the informed consent form prior to any study-related procedures.

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).

Subjects are able to communicate effectively with the investigators and can understand and comply with all study requirements.

Disqualifiers

Known allergy to methylconalamin injection, methylconalamin injection, or any component of the formulations, or history of hypersensitivity (e.g., rash, urticaria).

History of clinically significant diseases or any other medical or physiological condition that could interfere with study results, including but not limited to disorders of the hematologic, cardiovascular, digestive, urinary, respiratory, nervous, immune, or endocrine systems, malignancy, psychiatric disorders, or metabolic abnormalities.

History of significant bleeding tendency, coagulation disorders, systemic bleeding, neutropenia, or thrombocytopenia.

Vaccination with any vaccine or live attenuated vaccine within 1 month prior to dosing, or planned vaccination during the study.

Trial design

Design model

Crossover

Treatments tested in this trial

  • Methylconalamin Injection(WP205)

    Drug

    25 mg intramuscular injection in the upper-arm deltoid

  • Methylconalamin for Injection

    Drug

    25 mg intramuscular injection in the upper-arm deltoid

Treatment groups

14 Participants
are divided into 2 treatment groups
Group A: Group AExperimental treatment 2 interventions
Group B: Group BActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Peak Plasma Concentration (Cmax)

Time frame
0 to 24 hours after each single intramuscular dose
2

Area under the plasma concentration versus time curve (AUC)0-t

Time frame
0 to 24 hours after each single intramuscular dose
3

Area under the plasma concentration versus time curve (AUC)0-∞

Time frame
0 to 24 hours after each single intramuscular dose

Secondary outcomes

1

Safety

Monitor all the adverse event

Time frame
7 days

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wanbangde Pharmaceutical Group Co., LTD

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: