Therapeutic Equivalency, HealthyPhase 1NCT07281872
Bioequivalence Study of WP205 in Healthy Participants
A Phase 1 study testing Methylcobalamin Injection(WP205) and Methylcobalamin for Injection in people with Therapeutic Equivalency, Healthy, run by Wanbangde Pharmaceutical Group Co., LTD at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Therapeutic Equivalency, Healthy
- What is being tested?
- Methylcobalamin Injection(WP205) and Methylcobalamin for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 29 Oct 2025to 21 Nov 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Known allergy to methylcobalamin injection, methylcobalamin 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.
- 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).
- 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.
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- 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).
- 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.
- 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.
- Smoking ≥5 cigarettes/day within 3 months prior to screening, or inability to stop tobacco use during the study, or positive nicotine test.
- History of substance abuse within 3 months prior to screening, or positive drug screening.
- 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.
- 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.
- Use of any investigational drug or participation in any drug/device clinical trial within 1 months prior to screening.
- Clinically significant abnormalities in vital signs, physical examination, laboratory tests (hematology, urinalysis, blood biochemistry, coagulation), chest X-ray, or 12-lead ECG.
- Positive test for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), syphilis antibody (anti-TP), or HIV antibody (anti-HIV).
- Subjects with special dietary requirements unable to comply with standardized study diet.
- Subjects unable to tolerate venipuncture or with difficult venous access, or history of orthostatic hypotension, syncope, or needle phobia.
- 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.
- Subjects deemed unsuitable for participation by their own reason or at the investigator's discretion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Therapeutic Equivalency, Healthy
- Being tested
- Methylcobalamin Injection(WP205), Methylcobalamin for Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylcobalamin Injection(WP205)Drug
25 mg intramuscular injection in the upper-arm deltoid
Methylcobalamin for InjectionDrug
25 mg intramuscular injection in the upper-arm deltoid
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Not described Receives: Drug: Methylcobalamin Injection(WP205); Drug: Methylcobalamin for Injection |
| Group B | Active comparator | Not described Receives: Drug: Methylcobalamin Injection(WP205); Drug: Methylcobalamin for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Plasma Concentration (Cmax)
Measured: 0 to 24 hours after each single intramuscular dose
Area under the plasma concentration versus time curve (AUC)0-t
Measured: 0 to 24 hours after each single intramuscular dose
Area under the plasma concentration versus time curve (AUC)0-∞
Measured: 0 to 24 hours after each single intramuscular dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start29 Oct 2025
- Primary completion6 Nov 2025
- Study completion21 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Therapeutic Equivalency, HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wanbangde Pharmaceutical Group Co., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07281872
- Sponsor's protocol ID
- WBD-JGAZSY-I02
- Status last verified
- Aug 2026
- First submitted
- 19 Nov 2025
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07281872
- Acronym / sponsor ID
- WBD-JGAZSY-I02
- Conditions
- Therapeutic Equivalency, Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Wanbangde Pharmaceutical Group Co., LTDIndustry (pharma, biotech, devices)
- Study start
- 29 Oct 2025 (actual)
- Primary completion
- 6 Nov 2025 (actual)
- Study completion
- 21 Nov 2025 (actual)
- First posted
- 15 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Methylcobalamin Injection(WP205), Drug: Methylcobalamin for Injection |
| Group B | Active comparator | Drug: Methylcobalamin Injection(WP205), Drug: Methylcobalamin for Injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (20 listed)
- Known allergy to methylcobalamin injection, methylcobalamin 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.
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methylcobalamin Injection(WP205)25 mg intramuscular injection in the upper-arm deltoid | Drug | Group A, Group B |
| Methylcobalamin for Injection25 mg intramuscular injection in the upper-arm deltoid | Drug | Group A, Group B |
Primary outcome
Peak Plasma Concentration (Cmax)
Time frame: 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
Area under the plasma concentration versus time curve (AUC)0-∞
Time frame: 0 to 24 hours after each single intramuscular dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Methylcobalamin Injection(WP205) and Methylcobalamin for Injection in people with Therapeutic Equivalency, Healthy, run by Wanbangde Pharmaceutical Group Co., LTD at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Plasma Concentration (Cmax) (time frame: 0 to 24 hours after each single intramuscular dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.