Bioequivalence Study of WP205 in Healthy Participants

August 20, 2026 updated by: Wanbangde Pharmaceutical Group Co., LTD

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Zhejiang Provincial People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. 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.
  2. Male or female subjects aged 18 years or older, with an appropriate gender distribution.
  3. 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).
  4. Subjects are able to communicate effectively with the investigators and can understand and comply with all study requirements.

Exclusion Criteria:

  1. Known allergy to methylcobalamin injection, methylcobalamin injection, or any component of the formulations, or history of hypersensitivity (e.g., rash, urticaria).
  2. 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.
  3. History of significant bleeding tendency, coagulation disorders, systemic bleeding, neutropenia, or thrombocytopenia.
  4. Vaccination with any vaccine or live attenuated vaccine within 1 month prior to dosing, or planned vaccination during the study.
  5. Consumption within 48 hours prior to dosing of foods or beverages that may affect metabolism (e.g., grapefruit, pomelo, mango, orange), alcohol, purine-rich or caffeine-containing foods/beverages (e.g., coffee, strong tea, chocolate), or foods rich in vitamin B12 (e.g., animal liver such as pork, beef, chicken, and shellfish such as oysters or clams).
  6. Daily excessive consumption of tea, coffee, and/or caffeine-containing beverages (≥8 cups per day, 1 cup = 250 mL) within 3 months prior to screening.
  7. Use of any drugs that affect liver enzyme activity within 30 days prior to first dose (e.g., enzyme inducers such as barbiturates, carbamazepine, phenytoin, dexamethasone; inhibitors such as SSRIs, ciprofloxacin, diltiazem, macrolides, metronidazole, ketoconazole, verapamil, fluoroquinolones).
  8. Use of any medication (prescription, over-the-counter, herbal, vitamin, or dietary supplement) within 2 weeks prior to screening, except for topical medications or eye drops with local effects.
  9. Weekly alcohol consumption exceeding 14 units within 3 months prior to screening (1 unit ≈ 360 mL beer or 45 mL spirits with 40% alcohol or 150 mL wine), or positive alcohol breath test, or inability to abstain from alcohol during the study.
  10. Smoking ≥5 cigarettes/day within 3 months prior to screening, or inability to stop tobacco use during the study, or positive nicotine test.
  11. History of substance abuse within 3 months prior to screening, or positive drug screening.
  12. Blood donation or significant blood loss (≥400 mL), transfusion, or use of blood products within 3 months prior to screening, or planned blood donation during the study or within 3 months after study completion.
  13. History of surgery within 3 months prior to screening, planned surgery during the study, or history of surgery that may affect drug absorption, distribution, metabolism, or excretion.
  14. Use of any investigational drug or participation in any drug/device clinical trial within 1 months prior to screening.
  15. Clinically significant abnormalities in vital signs, physical examination, laboratory tests (hematology, urinalysis, blood biochemistry, coagulation), chest X-ray, or 12-lead ECG.
  16. Positive test for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), syphilis antibody (anti-TP), or HIV antibody (anti-HIV).
  17. Subjects with special dietary requirements unable to comply with standardized study diet.
  18. Subjects unable to tolerate venipuncture or with difficult venous access, or history of orthostatic hypotension, syncope, or needle phobia.
  19. Male (or their partner) or female subjects planning pregnancy, egg/sperm donation, unwilling to use effective contraception, positive pregnancy test, or lactating females from signing consent to 1 month after last dose.
  20. Subjects deemed unsuitable for participation by their own reason or at the investigator's discretion.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group A
Drug: Methylcobalamin Injection(WP205)
25 mg intramuscular injection in the upper-arm deltoid
Drug: Methylcobalamin for Injection
25 mg intramuscular injection in the upper-arm deltoid
Active Comparator: Group B
Drug: Methylcobalamin Injection(WP205)
25 mg intramuscular injection in the upper-arm deltoid
Drug: Methylcobalamin for Injection
25 mg intramuscular injection in the upper-arm deltoid

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Peak Plasma Concentration (Cmax)
Time Frame: 0 to 24 hours after each single intramuscular dose
0 to 24 hours after each single intramuscular dose
Area under the plasma concentration versus time curve (AUC)0-t
Time Frame: 0 to 24 hours after each single intramuscular dose
0 to 24 hours after each single intramuscular dose
Area under the plasma concentration versus time curve (AUC)0-∞
Time Frame: 0 to 24 hours after each single intramuscular dose
0 to 24 hours after each single intramuscular dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wanbangde Pharmaceutical Group Co., LTD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 29, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 6, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 21, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 19, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 15, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • WBD-JGAZSY-I02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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