Myasthenia GravisPhase 1NCT07154095
A Single-Center, Randomized, Open-Label, Two-Sequence, Two-Period, Crossover Study Comparing the Pharmacokinetics and Safety of Pyridostigmine Sustained-Release and Immediate-Release Tablets Following Single and Multiple Doses in Healthy Chinese Participants
A Phase 1 study testing Sustained-Release Tablets and Immediate-Release Tablets in people with Myasthenia Gravis and Pharmacokinetics, run by West China Second University Hospital at 1 site in China.
Trial summary
This study aimed to assess the pharmacokinetic profile, safety, and tolerability of a new sustained-release pyridostigmine tablet versus the reference product. The evaluation was conducted in healthy participants following both single and multiple dosing. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Myasthenia Gravis, Pharmacokinetics
- What is being tested?
- Sustained-Release Tablets and Immediate-Release Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 10 Aug 2023to 6 Feb 2024
- 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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged between 18 and 45 years (inclusive), male or female;
- Weight: male ≥50 kg, female ≥45 kg; body mass index (BMI) within the range of 19-26 kg/m² (inclusive);
- Normal or abnormal without clinical significance in physical examination, vital signs, 12-lead electrocardiogram (ECG), laboratory tests, and chest X-ray;
- 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;
- 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;
- 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.
Who cannot join
- Known history of allergy to the investigational drug or any of its components, or related preparations; history of allergic diseases or allergic constitution;
- 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;
- 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;
- Difficulty in blood collection or inability to comply with a standardized diet;
- 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;
- Smoking ≥10 cigarettes per day;
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- 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;
- History of drug abuse or drug dependence, or positive urine drug abuse screening (morphine, tetrahydrocannabinol, methamphetamine, methylenedioxymethamphetamine, ketamine);
- 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;
- Participation in any other clinical trial and receipt of an investigational drug within 3 months prior to the first dose;
- Lactating females or those with a positive pregnancy test (applicable to female participants);
- Other factors deemed by the investigators to be unsuitable for participation in the trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Center, Randomized, Open-Label, Two-Sequence, Two-Period, Crossover Study to Compare the Pharmacokinetics and Safety of Pyridostigmine Sustained-Release Tablets and Pyridostigmine Tablets Following Single and Multiple Doses in Healthy Chinese Participants
This study aimed to assess the pharmacokinetic profile, safety, and tolerability of a new sustained-release pyridostigmine tablet versus the reference product. The evaluation was conducted in healthy participants following both single and multiple dosing.
- Conditions
- Myasthenia Gravis, Pharmacokinetics
- Being tested
- Sustained-Release Tablets, Immediate-Release Tablets
- Medical subject headings
- Myasthenia Gravis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sustained-Release TabletsDrug
A single-center, randomized, open-label, two-sequence, two-period, crossover design was employed. Forty healthy participants were enrolled and randomized (1:1) into two sequences (AB and BA) to receive both the test and reference formulations across two periods, separated by a washout interval of at least 5 days.
Immediate-Release TabletsDrug
Also called MESTINON®
A single-center, randomized, open-label, two-sequence, two-period, crossover design was employed. Forty healthy participants were enrolled and randomized (1:1) into two sequences (AB and BA) to receive both the test and reference formulations across two periods, separated by a washout interval of at least 5 days.
| Study group | Role | What they receive |
|---|---|---|
| sustained-release pyridostigmine tablet | Experimental | Not described Receives: Drug: Sustained-Release Tablets |
| Immediate-Release Tablets | Active comparator | Not described Receives: Drug: Immediate-Release Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tmax
Time to Reach Maximum Concentration
Measured: Blood sampling: Within 1 hour pre-dose and 24 hours post-dose on Day 1; within 5 to 2 minutes pre-dose and 24 hours post-dose on Day 5.
Cmax
Peak Concentration
Measured: Blood sampling: Within 1 hour pre-dose and 24 hours post-dose on Day 1; within 5 to 2 minutes pre-dose and 24 hours post-dose on Day 5.
AUC
Area under the plasma concentration-time curve
Measured: Blood sampling: Within 1 hour pre-dose and 24 hours post-dose on Day 1; within 5 to 2 minutes pre-dose and 24 hours post-dose on Day 5.
Secondary outcomes (1)
TEAE
Treatment-emergent adverse event (TEAE): any adverse event that first appears or worsens in severity after initiation of study treatment
Measured: From first dose of study drug up to a maximum of 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start10 Aug 2023
- Primary completion22 Nov 2023
- Study completion6 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myasthenia GravisStudies 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
- Model description
- A single-center, randomized, open-label, two-sequence, two-period, crossover design
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- West China Second University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu Qin, West China Second University Hospital
- Investigators
- Yu Qin, Principal investigator, China West China Second University Hospital Chengdu, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07154095
- Sponsor's protocol ID
- CRC-C2142
- Status last verified
- Sep 2025
- First submitted
- 25 Aug 2025
- Last updated
- 4 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Randomized, Open-Label, Two-Sequence, Two-Period, Crossover Study to Compare the Pharmacokinetics and Safety of Pyridostigmine Sustained-Release Tablets and Pyridostigmine Tablets Following Single and Multiple Doses in Healthy Chinese Participants
- ClinicalTrials.gov ID
- NCT07154095
- Acronym / sponsor ID
- CRC-C2142
- Conditions
- Myasthenia Gravis, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- West China Second University HospitalUniversity, hospital or other
- Study start
- 10 Aug 2023 (actual)
- Primary completion
- 22 Nov 2023 (actual)
- Study completion
- 6 Feb 2024 (actual)
- First posted
- 4 Sep 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 aimed to assess the pharmacokinetic profile, safety, and tolerability of a new sustained-release pyridostigmine tablet versus the reference product. The evaluation was conducted in healthy participants following both single and multiple dosing.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A single-center, randomized, open-label, two-sequence, two-period, crossover design
| Arm | Type | Receives |
|---|---|---|
| sustained-release pyridostigmine tablet | Experimental | Drug: Sustained-Release Tablets |
| Immediate-Release Tablets | Active comparator | Drug: Immediate-Release Tablets |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Aged between 18 and 45 years (inclusive), male or female;
- Weight: male ≥50 kg, female ≥45 kg; body mass index (BMI) within the range of 19-26 kg/m² (inclusive);
- Normal or abnormal without clinical significance in physical examination, vital signs, 12-lead electrocardiogram (ECG), laboratory tests, and chest X-ray;
- 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;
- 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;
Key exclusion criteria (12 listed)
- Known history of allergy to the investigational drug or any of its components, or related preparations; history of allergic diseases or allergic constitution;
- 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;
- 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;
- Difficulty in blood collection or inability to comply with a standardized diet;
- 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;
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 |
|---|---|---|
| Sustained-Release TabletsA single-center, randomized, open-label, two-sequence, two-period, crossover design was employed. Forty healthy participants were enrolled and randomized (1:1) into two sequences (AB and BA) to receive both the test and reference formulations across two periods, separated by a washout interval of at least 5 days. | Drug | sustained-release pyridostigmine tablet |
| Immediate-Release TabletsAlso: MESTINON®A single-center, randomized, open-label, two-sequence, two-period, crossover design was employed. Forty healthy participants were enrolled and randomized (1:1) into two sequences (AB and BA) to receive both the test and reference formulations across two periods, separated by a washout interval of at least 5 days. | Drug | Immediate-Release Tablets |
Primary outcome
Tmax
Time frame: Blood sampling: Within 1 hour pre-dose and 24 hours post-dose on Day 1; within 5 to 2 minutes pre-dose and 24 hours post-dose on Day 5.
Time to Reach Maximum Concentration
Cmax
Time frame: Blood sampling: Within 1 hour pre-dose and 24 hours post-dose on Day 1; within 5 to 2 minutes pre-dose and 24 hours post-dose on Day 5.
Peak Concentration
AUC
Time frame: Blood sampling: Within 1 hour pre-dose and 24 hours post-dose on Day 1; within 5 to 2 minutes pre-dose and 24 hours post-dose on Day 5.
Area under the plasma concentration-time curve
1 secondary outcome
TEAE
Time frame: From first dose of study drug up to a maximum of 6 days
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 4 Sep 2025.
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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.
Yu Qin principal investigator
China West China Second University Hospital Chengdu, China
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 Sustained-Release Tablets and Immediate-Release Tablets in people with Myasthenia Gravis and Pharmacokinetics, run by West China Second University Hospital 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 6 inclusion and 12 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 4 Sep 2025. 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?
Tmax (time frame: Blood sampling: Within 1 hour pre-dose and 24 hours post-dose on Day 1; within 5 to 2 minutes pre-dose and 24 hours post-dose on Day 5.). 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 4 Sep 2025.