Bioequivalence Study of WP205 in Healthy Participants (NCT07281872) | Clinical Trial Compass
CompletedPhase 1
Bioequivalence Study of WP205 in Healthy Participants
China20 participantsStarted 2025-10-29
Plain-language 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). 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. Known allergy to methylconalamin injection, methylconalamin injection, or any component of the formulations, or history of hypersensitivity (e.g., rash, urticaria).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Peak Plasma Concentration (Cmax)
Timeframe: 0 to 24 hours after each single intramuscular dose
2
Area under the plasma concentration versus time curve (AUC)0-t
Timeframe: 0 to 24 hours after each single intramuscular dose
3
Area under the plasma concentration versus time curve (AUC)0-∞
Timeframe: 0 to 24 hours after each single intramuscular dose
. 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.
. 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.