HealhtyPhase 1NCT07910682
Bioequivalence of Sitagliptin/Metformin Tablets in Healthy Chinese Adults Under Fasting and Fed Conditions
A Phase 1 study testing Sitagliptin/metformin hydrochloride tablets (50 mg/850 mg) and Sitagliptin/metformin hydrochloride reference tablets (50 mg/850 mg) in people with Healhty, run by Guangzhou Panyu Central Hospital at 1 site in China.
Trial summary
This study evaluated whether a test formulation of sitagliptin/metformin tablets (manufactured by Jiangxi Shimei Pharmaceutical Co., Ltd.) is bioequivalent to the reference product Janumet (sitagliptin phosphate/metformin hydrochloride tablets, MSD) in healthy Chinese adults. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healhty
- What is being tested?
- Sitagliptin/metformin hydrochloride tablets (50 mg/850 mg) and Sitagliptin/metformin hydrochloride reference tablets (50 mg/850 mg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteChina
- Study dates
- 27 Feb 2025to 26 Mar 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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Fully understood the study objectives and voluntarily signed the informed consent form.
- Healthy male or female aged 18-45 years (inclusive).
- Body weight >= 50 kg for males and >= 45 kg for females, and body mass index 19.0-26.0 kg/m2 (inclusive).
- Vital signs, physical examination, clinical laboratory tests, and 12-lead electrocardiogram findings normal, or abnormal without clinical significance.
Who cannot join
- Failure to meet the inclusion criteria after physician assessment based on physical examination.
- Presence of dysphagia or gastrointestinal, hepatic, or renal diseases that might affect the pharmacokinetic behaviour of the study drug.
- Occurrence of diarrhoea or constipation within 14 days prior to the trial.
- Special dietary requirements, inability to accept a standardised diet, or history of food or drug allergy or other allergic diseases.
- Participation in another clinical trial within 3 months prior to the trial, or excessive consumption of tea, coffee or caffeinated beverages, heavy smoking, alcohol or drug abuse, or history of blood donation.
- Use of any medication or receipt of any vaccine within 2 weeks prior to the trial.
- Positive test for hepatitis B surface antigen, hepatitis C antibody, human immunodeficiency virus antibody, or syphilis antibody.
- Major surgery within 6 months prior to the trial.
Trial locations and contacts
1 site in 1 country.
China1 site
The Affiliated Panyu Central Hospital, Guangzhou Medical University
Guangzhou, Guangdong, 511400
About this study
Official title: A Single-Centre, Randomised, Open-Label, Two-Period, Two-Sequence Crossover Study to Evaluate the Bioequivalence of Sitagliptin/Metformin Hydrochloride Tablets (50 mg/850 mg) in Healthy Chinese Subjects Under Fasting and Fed Conditions
This study evaluated whether a test formulation of sitagliptin/metformin tablets (manufactured by Jiangxi Shimei Pharmaceutical Co., Ltd.) is bioequivalent to the reference product Janumet (sitagliptin phosphate/metformin hydrochloride tablets, MSD) in healthy Chinese adults. The study was conducted as two independent cohorts (fasting and fed) at a single centre. Each cohort used a randomised, open-label, two-period, two-sequence, single-dose crossover design with a 7-day washout between periods, and 28 subjects were enrolled in each cohort. In each period, subjects received a single oral dose of the test or the reference product, and serial blood samples were collected up to 48 hours after dosing to determine plasma sitagliptin and metformin concentrations with a validated analytical method. The primary pharmacokinetic parameters were Cmax, AUC0-t and AUC0-inf. Bioequivalence was to be concluded if the 90% confidence intervals of the geometric mean ratios (test/reference) for these parameters fell within the predefined acceptance range of 80.00%-125.00%. Safety was assessed throughout the study.
Read the detailed description
Eligible subjects were healthy Chinese adults aged 18 to 45 years with a body mass index of 19.0-26.0 kg/m2, who gave written informed consent. Subjects were admitted to the clinical unit on the day before dosing and remained under supervision until the end of the 48-hour sampling period.
In each period, after an overnight fast of at least 10 hours, subjects in the fasting cohort received a single oral dose of the test or reference product with approximately 240 mL of 20% glucose solution, followed by 60 mL of 20% glucose solution at 1.0, 2.0, 3.0 and 4.0 hours post-dose. Subjects in the fed cohort received a standard high-fat, high-calorie meal, and the dose was administered 30 +/- 0.5 minutes after the start of the meal with approximately 240 mL of 20% glucose solution, followed by 60 mL of 20% glucose solution at 1.0, 2.0, 3.0 and 4.0 hours post-dose. A 7-day washout period separated the two periods.
Blood samples were collected pre-dose and at 0.17, 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.5, 5, 5.5, 6, 7, 9, 12, 16, 24, 36 and 48 hours post-dose (25 time points per period).
Plasma concentrations of sitagliptin and metformin were determined with a validated LC-MS/MS method. Pharmacokinetic parameters were calculated by non-compartmental analysis, and log-transformed Cmax, AUC0-t and AUC0-inf were compared between the test and reference products by analysis of variance. Bioequivalence was concluded if the 90% confidence intervals of the geometric mean ratios fell within 80.00%-125.00%. Adverse events were recorded throughout the study.
- Conditions
- Healhty
- Being tested
- Sitagliptin/metformin hydrochloride tablets (50 mg/850 mg), Sitagliptin/metformin hydrochloride reference tablets (50 mg/850 mg)
- Keywords
- bioequivalence, sitagliptin, metformin, healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sitagliptin/metformin hydrochloride tablets (50 mg/850 mg)Drug
Test formulation: sitagliptin/metformin hydrochloride tablets (II), strength 50 mg/850 mg, manufactured by Jiangxi Shimei Pharmaceutical Co., Ltd, China. Administered as a single oral dose (one tablet) with 240 mL of 20% glucose solution in each treatment period.
Sitagliptin/metformin hydrochloride reference tablets (50 mg/850 mg)Drug
Also called Janumet
Reference formulation: Janumet, sitagliptin/metformin hydrochloride tablets (II), strength 50 mg/850 mg, manufactured by Patheon Puerto Rico, Inc. (Manati), United States. Administered as a single oral dose (one tablet) with 240 mL of 20% glucose solution in each treatment period.
| Study group | Role | What they receive |
|---|---|---|
| Fasting condition cohort | Experimental | Twenty-eight healthy adult subjects were randomised to a two-period, two-sequence crossover and received a single oral dose of the test or the reference product under fasting conditions in each period, with a 7-day washout between periods. Receives: Drug: Sitagliptin/metformin hydrochloride tablets (50 mg/850 mg); Drug: Sitagliptin/metformin hydrochloride reference tablets (50 mg/850 mg) |
| Fed condition cohort | Experimental | Twenty-eight healthy adult subjects were randomised to a two-period, two-sequence crossover and received a single oral dose of the test or the reference product after a standard high-fat, high-calorie meal in each period, with a 7-day washout between periods. Receives: Drug: Sitagliptin/metformin hydrochloride tablets (50 mg/850 mg); Drug: Sitagliptin/metformin hydrochloride reference tablets (50 mg/850 mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of sitagliptin
Peak plasma concentration of sitagliptin, derived from plasma concentration-time data by non-compartmental analysis.
Measured: Pre-dose and up to 48 hours post-dose in each treatment period.
AUC0-t of sitagliptin
Area under the plasma concentration-time curve of sitagliptin from time zero to the last quantifiable concentration, calculated by non-compartmental analysis.
Measured: Pre-dose and up to 48 hours post-dose in each treatment period.
AUC0-inf of sitagliptin
Area under the plasma concentration-time curve of sitagliptin from time zero extrapolated to infinity, calculated by non-compartmental analysis.
Measured: Pre-dose and up to 48 hours post-dose in each treatment period.
Cmax of metformin
Peak plasma concentration of metformin, derived from plasma concentration-time data by non-compartmental analysis.
Measured: Pre-dose and up to 48 hours post-dose in each treatment period.
AUC0-t of metformin
Area under the plasma concentration-time curve of metformin from time zero to the last quantifiable concentration, calculated by non-compartmental analysis.
Measured: Pre-dose and up to 48 hours post-dose in each treatment period.
AUC0-inf of metformin
Area under the plasma concentration-time curve of metformin from time zero extrapolated to infinity, calculated by non-compartmental analysis.
Measured: Pre-dose and up to 48 hours post-dose in each treatment period.
Secondary outcomes (2)
Tmax of sitagliptin and metformin
Time to reach peak plasma concentration of sitagliptin and metformin, obtained directly from the concentration-time data.
Measured: Pre-dose and up to 48 hours post-dose in each treatment period.
Number of participants with adverse events
Incidence, severity, and relationship to study drug of adverse events, assessed from vital signs, physical examination, 12-lead electrocardiogram, and clinical laboratory tests.
Measured: Pre-dose and up to 48 hours post-dose in each treatment period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start27 Feb 2025
- Primary completion26 Mar 2025
- Study completion26 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealhtyStudies 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
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangzhou Panyu Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hui Yang, Guangzhou Panyu Central Hospital
- Investigators
- Hui Yang, Principal investigator, Guangzhou Panyu Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07910682
- Sponsor's protocol ID
- 2024-BE-XGLTEJSGP-01
- Other IDs
- CTR20250359
- Status last verified
- Oct 2026
- First submitted
- 27 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual de-identified participant-level plasma concentration data are available from the corresponding author (sugarchen2206@163.com) on reasonable request. All other data generated or analysed during this study are included in the published article.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Centre, Randomised, Open-Label, Two-Period, Two-Sequence Crossover Study to Evaluate the Bioequivalence of Sitagliptin/Metformin Hydrochloride Tablets (50 mg/850 mg) in Healthy Chinese Subjects Under Fasting and Fed Conditions
- ClinicalTrials.gov ID
- NCT07910682
- Acronym / sponsor ID
- 2024-BE-XGLTEJSGP-01
- Conditions
- Healhty
- Keywords
- bioequivalence, sitagliptin, metformin, healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Guangzhou Panyu Central HospitalUniversity, hospital or other
- Study start
- 27 Feb 2025 (actual)
- Primary completion
- 26 Mar 2025 (actual)
- Study completion
- 26 Mar 2025 (actual)
- First posted
- 2 Nov 2026 (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 evaluated whether a test formulation of sitagliptin/metformin tablets (manufactured by Jiangxi Shimei Pharmaceutical Co., Ltd.) is bioequivalent to the reference product Janumet (sitagliptin phosphate/metformin hydrochloride tablets, MSD) in healthy Chinese adults. The study was conducted as two independent cohorts (fasting and fed) at a single centre. Each cohort used a randomised, open-label, two-period, two-sequence, single-dose crossover design with a 7-day washout between periods, and 28 subjects were enrolled in each cohort. In each period, subjects received a single oral dose of the test or the reference product, and serial blood samples were collected up to 48 hours after dosing to determine plasma sitagliptin and metformin concentrations with a validated analytical method. The primary pharmacokinetic parameters were Cmax, AUC0-t and AUC0-inf. Bioequivalence was to be concluded if the 90% confidence intervals of the geometric mean ratios (test/reference) for these parameters fell within the predefined acceptance range of 80.00%-125.00%. Safety was assessed throughout the study.
Detailed description
Eligible subjects were healthy Chinese adults aged 18 to 45 years with a body mass index of 19.0-26.0 kg/m2, who gave written informed consent. Subjects were admitted to the clinical unit on the day before dosing and remained under supervision until the end of the 48-hour sampling period.
In each period, after an overnight fast of at least 10 hours, subjects in the fasting cohort received a single oral dose of the test or reference product with approximately 240 mL of 20% glucose solution, followed by 60 mL of 20% glucose solution at 1.0, 2.0, 3.0 and 4.0 hours post-dose. Subjects in the fed cohort received a standard high-fat, high-calorie meal, and the dose was administered 30 +/- 0.5 minutes after the start of the meal with approximately 240 mL of 20% glucose solution, followed by 60 mL of 20% glucose solution at 1.0, 2.0, 3.0 and 4.0 hours post-dose. A 7-day washout period separated the two periods.
Blood samples were collected pre-dose and at 0.17, 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.5, 5, 5.5, 6, 7, 9, 12, 16, 24, 36 and 48 hours post-dose (25 time points per period).
Plasma concentrations of sitagliptin and metformin were determined with a validated LC-MS/MS method. Pharmacokinetic parameters were calculated by non-compartmental analysis, and log-transformed Cmax, AUC0-t and AUC0-inf were compared between the test and reference products by analysis of variance. Bioequivalence was concluded if the 90% confidence intervals of the geometric mean ratios fell within 80.00%-125.00%. Adverse events were recorded throughout the study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fasting condition cohort | Experimental | Drug: Sitagliptin/metformin hydrochloride tablets (50 mg/850 mg), Drug: Sitagliptin/metformin hydrochloride reference tablets (50 mg/850 mg)Twenty-eight healthy adult subjects were randomised to a two-period, two-sequence crossover and received a single oral dose of the test or the reference product under fasting conditions in each period, with a 7-day washout between periods. |
| Fed condition cohort | Experimental | Drug: Sitagliptin/metformin hydrochloride tablets (50 mg/850 mg), Drug: Sitagliptin/metformin hydrochloride reference tablets (50 mg/850 mg)Twenty-eight healthy adult subjects were randomised to a two-period, two-sequence crossover and received a single oral dose of the test or the reference product after a standard high-fat, high-calorie meal in each period, with a 7-day washout between periods. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Fully understood the study objectives and voluntarily signed the informed consent form.
- Healthy male or female aged 18-45 years (inclusive).
- Body weight >= 50 kg for males and >= 45 kg for females, and body mass index 19.0-26.0 kg/m2 (inclusive).
- Vital signs, physical examination, clinical laboratory tests, and 12-lead electrocardiogram findings normal, or abnormal without clinical significance.
Key exclusion criteria (8 listed)
- Failure to meet the inclusion criteria after physician assessment based on physical examination.
- Presence of dysphagia or gastrointestinal, hepatic, or renal diseases that might affect the pharmacokinetic behaviour of the study drug.
- Occurrence of diarrhoea or constipation within 14 days prior to the trial.
- Special dietary requirements, inability to accept a standardised diet, or history of food or drug allergy or other allergic diseases.
- Participation in another clinical trial within 3 months prior to the trial, or excessive consumption of tea, coffee or caffeinated beverages, heavy smoking, alcohol or drug abuse, or history of blood donation.
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 |
|---|---|---|
| Sitagliptin/metformin hydrochloride tablets (50 mg/850 mg)Test formulation: sitagliptin/metformin hydrochloride tablets (II), strength 50 mg/850 mg, manufactured by Jiangxi Shimei Pharmaceutical Co., Ltd, China. Administered as a single oral dose (one tablet) with 240 mL of 20% glucose solution in each treatment period. | Drug | Fasting condition cohort, Fed condition cohort |
| Sitagliptin/metformin hydrochloride reference tablets (50 mg/850 mg)Also: JanumetReference formulation: Janumet, sitagliptin/metformin hydrochloride tablets (II), strength 50 mg/850 mg, manufactured by Patheon Puerto Rico, Inc. (Manati), United States. Administered as a single oral dose (one tablet) with 240 mL of 20% glucose solution in each treatment period. | Drug | Fasting condition cohort, Fed condition cohort |
Primary outcome
Cmax of sitagliptin
Time frame: Pre-dose and up to 48 hours post-dose in each treatment period.
Peak plasma concentration of sitagliptin, derived from plasma concentration-time data by non-compartmental analysis.
AUC0-t of sitagliptin
Time frame: Pre-dose and up to 48 hours post-dose in each treatment period.
Area under the plasma concentration-time curve of sitagliptin from time zero to the last quantifiable concentration, calculated by non-compartmental analysis.
AUC0-inf of sitagliptin
Time frame: Pre-dose and up to 48 hours post-dose in each treatment period.
Area under the plasma concentration-time curve of sitagliptin from time zero extrapolated to infinity, calculated by non-compartmental analysis.
Cmax of metformin
Time frame: Pre-dose and up to 48 hours post-dose in each treatment period.
Peak plasma concentration of metformin, derived from plasma concentration-time data by non-compartmental analysis.
AUC0-t of metformin
Time frame: Pre-dose and up to 48 hours post-dose in each treatment period.
Area under the plasma concentration-time curve of metformin from time zero to the last quantifiable concentration, calculated by non-compartmental analysis.
AUC0-inf of metformin
Time frame: Pre-dose and up to 48 hours post-dose in each treatment period.
Area under the plasma concentration-time curve of metformin from time zero extrapolated to infinity, calculated by non-compartmental analysis.
2 secondary outcomes
Tmax of sitagliptin and metformin
Time frame: Pre-dose and up to 48 hours post-dose in each treatment period.
Number of participants with adverse events
Time frame: Pre-dose and up to 48 hours post-dose in each treatment period.
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 2 Nov 2026.
- Individual participant dataSharing planned: Yes. Individual de-identified participant-level plasma concentration data are available from the corresponding author (sugarchen2206@163.com) on reasonable request. All other data generated or analysed during this study are included in the published article.
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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.
Hui Yang principal investigator
Guangzhou Panyu Central Hospital
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 Sitagliptin/metformin hydrochloride tablets (50 mg/850 mg) and Sitagliptin/metformin hydrochloride reference tablets (50 mg/850 mg) in people with Healhty, run by Guangzhou Panyu Central 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 4 inclusion and 8 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 2 Nov 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?
Cmax of sitagliptin (time frame: Pre-dose and up to 48 hours post-dose in each treatment period.). The study lists 6 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 2 Nov 2026.