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New Slow-Release pill for muscle disease tested in healthy volunteers

NCT ID NCT07154095

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested a new sustained-release (long-acting) version of pyridostigmine, a drug used for myasthenia gravis (a muscle weakness disease). Forty healthy Chinese adults took both the new long-acting tablet and the standard immediate-release tablet at different times to compare how the drug moves through the body and to check for side effects. The goal is to see if the new version can provide steady drug levels with fewer daily doses.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
pyridostigmine
What this could lead to
If successful, this sustained-release tablet could allow people with myasthenia gravis to take medication less often while maintaining stable drug levels.
What could go wrong
This is an early-phase study in healthy volunteers, not patients. The new tablet may not work better or could cause unexpected side effects when tested in people with the disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

40 people

The number who actually took part.

Started

Aug 2023

Finished

Feb 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 45 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Aged between 18 and 45 years (inclusive), male or female; 2. Weight: male ≥50 kg, female ≥45 kg; body mass index (BMI) within the range of 19-26 kg/m² (inclusive); 3. Normal or abnormal without clinical significance in physical examination, vital signs, 12-lead electrocardiogram (ECG), laboratory tests, and chest X-ray; 4. Negative test results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab), and Treponema pallidum antibody; 5. No plans for childbearing or sperm/egg donation during the trial and for 3 months after the last dose, and willingness to use reliable contraceptive measures; 6. Ability to communicate well with the researchers, fully understand the purpose of the trial, comply with all requirements, voluntarily participate in the clinical trial, and provide written informed consent. Exclusion Criteria: 1. Known history of allergy to the investigational drug or any of its components, or related preparations; history of allergic diseases or allergic constitution; 2. History of any disease that may affect the safety of the participant or the pharmacokinetics of the investigational drug, including but not limited to central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, hematopoietic system, metabolic disorders (e.g., hyperkalemia), or other conditions unsuitable for clinical trials (e.g., psychiatric history), or history of mechanical intestinal obstruction, urinary tract obstruction, or bronchial asthma; 3. Chronic excessive consumption (more than 8 cups per day, 1 cup = 250 mL) of tea, coffee, or caffeine-containing beverages; or intake of any food or beverage containing caffeine, grapefruit, or poppy seeds (e.g., coffee, alcohol, strong tea, chocolate, grapefruit, pomelo, etc.) within 48 hours prior to the first dose; 4. Difficulty in blood collection or inability to comply with a standardized diet; 5. History of blood donation (including component blood donation) or blood loss ≥ 200 mL, or receipt of blood transfusion within 3 months prior to the first dose; 6. Smoking ≥10 cigarettes per day; 7. Positive alcohol breath test, or regular alcohol consumption (exceeding 21 units per week, 1 unit containing 14 g of alcohol, e.g., 360 mL of beer, 45 mL of 40% spirits, or 150 mL of wine) within 3 months prior to the first dose; 8. History of drug abuse or drug dependence, or positive urine drug abuse screening (morphine, tetrahydrocannabinol, methamphetamine, methylenedioxymethamphetamine, ketamine); 9. Use of any prescription drugs, herbal tonics, or any drugs that inhibit or induce liver drug metabolism within 1 month prior to the first dose, and/or use of any over-the-counter drugs or dietary supplements (including vitamins, calcium tablets, etc.) within 2 weeks prior to the first dose; 10. Participation in any other clinical trial and receipt of an investigational drug within 3 months prior to the first dose; 11. Lactating females or those with a positive pregnancy test (applicable to female participants); 12. Other factors deemed by the investigators to be unsuitable for participation in the trial

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • West China Second University Hospital

    Chengdu, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.