Healthy VolunteersPhase 1NCT07679711

Bioequivalence Study of Sitagliptin/Metformin Extended-Release Tablets in Healthy Subjects

A Phase 1 study testing Sitagliptin / Metformin hydrochloride extended-release tablet (Test) and Sitagliptin / Metformin hydrochloride extended-release tablet (Reference) in people with Healthy Volunteers, run by The Affiliated Hospital of Qingdao University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The main purpose of this study is to compare the pharmacokinetics (how the body absorbs and clears the drug) and evaluate the bioequivalence of two formulations of sitagliptin/metformin hydrochloride extended-release tablets (50 mg/500 mg) in healthy adult subjects. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: Sitagliptin / Metformin hydrochloride extended-release tablet (Test) and Sitagliptin / Metformin hydrochloride extended-release tablet (Reference)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 76 participants
Where: 1 siteChina
Study dates: 14 Feb 2023to 22 Mar 2023
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

Sign the informed consent form before the trial, and fully understand the trial content, process, and possible adverse reactions.
Able to complete the study according to the requirements of the study protocol.
Subjects voluntarily agree to use effective non-pharmacological contraception methods from the signing of informed consent (14 days prior to signing for female subjects) until 3 months after the last dose, with no plans for pregnancy, sperm donation, or egg donation.
Male and female subjects aged 18 years and above.
Male subjects weighing ≥ 50.0 kg and female subjects weighing ≥ 45.0 kg; Body Mass Index (BMI) within the range of 19.0 to 27.0 kg/m^2 (inclusive).

Who cannot join

History of specific allergies (e.g., urticaria, exfoliative dermatitis, angioedema, or bronchial hyperresponsiveness), or allergic constitution (e.g., allergic to two or more drugs, foods such as milk and pollen), or known allergy to the components or analogs of this drug.
Serious history of cardiovascular, hepatic, renal, gastrointestinal, neurological, endocrine, respiratory, or psychiatric abnormalities, which the investigator considers inappropriate for participation.
Clinically significant abnormal findings as judged by the investigator, including physical examination, vital signs, electrocardiogram, or clinical laboratory tests.
History of or current pancreatitis.
History of hypoglycemia.
Estimated glomerular filtration rate (eGFR) < 90 mL/min/1.73 m^2.

Show all 23Show fewer

History of dysphagia or any gastrointestinal disease affecting drug absorption (e.g., gastric or small bowel resection, atrophic gastritis, gastrointestinal bleeding, obstruction, etc.).
Difficulty in blood collection, intolerance to venipuncture, or history of needle/blood phobia.
Female subjects who are pregnant, lactating, or have a positive pregnancy test result.
Positive for any one or more of the following: Hepatitis B surface antigen, Hepatitis C antibody, HIV antibody, or Syphilis antibody.
History of drug abuse within 5 years, use of illicit drugs within 3 months prior to screening, or positive urine drug screen.
Consumption of more than 14 units of alcohol per week on average within 3 months prior to screening, or refusal to abstain from alcohol from 48 hours prior to dosing in each period until the end of blood collection for that period, or positive alcohol breath test.
Smoking more than 5 cigarettes per day on average within 3 months prior to screening, or refusal to abstain from using any tobacco products during the clinical stay.
History of surgery within 3 months prior to screening, or planned surgery during the study.
Blood donation or massive blood loss (>400 mL, excluding physiological blood loss in females) within 3 months prior to the first dose, or donation of 2 therapeutic units of platelets within 1 month.
Participation and drug administration in any clinical trial within 3 months prior to the first dose.
Use of any prescription drugs within 14 days prior to dosing.
Use of any over-the-counter drugs, herbal medicines, or dietary supplements within 7 days prior to dosing.
Consumption of special diets (e.g., grapefruit and products containing grapefruit ingredients) or strenuous exercise within 48 hours prior to dosing, or other factors affecting drug absorption, distribution, metabolism, and excretion.
Consumption of any xanthine-rich foods or beverages (e.g., coffee, tea, chocolate, cocoa, milk tea, etc.) within 48 hours prior to dosing.
Special dietary requirements, inability to comply with the diet and corresponding regulations provided by the center.
Occurrence of an acute illness during the pre-study screening phase or before study drug administration.
Other subjects deemed unsuitable for participation by the investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266000

Other trials in China

About this study

Official title: Bioequivalence Study of Two Formulations of a Sitagliptin/Metformin Hydrochloride Extended-Release Tablet in Healthy Chinese Subjects Under Fasting and Fed Conditions: A Randomized, Open-Label, Single-Dose, Crossover Trial

The study is designed as a single-center, open-label, randomized, single-dose, two-period, two-sequence crossover trial. It consists of two separate parts: a fasting study and a fed study.

Participants will be randomly assigned to receive either the test formulation or the reference formulation in the first period. After a washout period of at least 5 days, participants will receive the alternate formulation in the second period. Blood samples will be collected at designated time points before and after dosing to measure the blood concentration of sitagliptin and metformin. Safety will also be continuously monitored throughout the study by assessing adverse events, vital signs, electrocardiograms (ECGs), and clinical laboratory tests.

Conditions: Healthy Volunteers
Being tested: Sitagliptin / Metformin hydrochloride extended-release tablet (Test), Sitagliptin / Metformin hydrochloride extended-release tablet (Reference)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Sitagliptin / Metformin hydrochloride extended-release tablet (Test)Drug
A single oral dose of sitagliptin 50 mg / metformin hydrochloride 500 mg extended-release tablet manufactured by Qilu Pharmaceutical (Hainan) Co., Ltd., administered with 240 mL of warm water.
Sitagliptin / Metformin hydrochloride extended-release tablet (Reference)Drug
A single oral dose of sitagliptin 50 mg / metformin hydrochloride 500 mg extended-release tablet (Janumet XR) manufactured by Merck Sharp \& Dohme Corp., administered with 240 mL of warm water.

Study groups in NCT07679711
Study group	Role	What they receive
Fasting, Sequence T-R	Experimental	Participants in the fasting cohort receive the test product (Sitagliptin/Metformin extended-release tablet) in Period 1, followed by a washout period of at least 5 days, and then receive the reference product (Janumet XR) in Period 2. Receives: Drug: Sitagliptin / Metformin hydrochloride extended-release tablet (Test); Drug: Sitagliptin / Metformin hydrochloride extended-release tablet (Reference)
Fasting, Sequence R-T	Active comparator	Arm Description: Participants in the fasting cohort receive the reference product (Janumet XR) in Period 1, followed by a washout period of at least 5 days, and then receive the test product (Sitagliptin/Metformin extended-release tablet) in Period 2. Receives: Drug: Sitagliptin / Metformin hydrochloride extended-release tablet (Test); Drug: Sitagliptin / Metformin hydrochloride extended-release tablet (Reference)
Fed, Sequence T-R	Experimental	Participants in the fed cohort (after a high-fat, high-calorie meal) receive the test product (Sitagliptin/Metformin extended-release tablet) in Period 1, followed by a washout period of at least 5 days, and then receive the reference product (Janumet XR) in Period 2. Receives: Drug: Sitagliptin / Metformin hydrochloride extended-release tablet (Test); Drug: Sitagliptin / Metformin hydrochloride extended-release tablet (Reference)
Fed, Sequence R-T	Active comparator	Participants in the fed cohort (after a high-fat, high-calorie meal) receive the reference product (Janumet XR) in Period 1, followed by a washout period of at least 5 days, and then receive the test product (Sitagliptin/Metformin extended-release tablet) in Period 2. Receives: Drug: Sitagliptin / Metformin hydrochloride extended-release tablet (Test); Drug: Sitagliptin / Metformin hydrochloride extended-release tablet (Reference)

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Observed Plasma Concentration (Cmax) of Sitagliptin and Metformin
Cmax will be obtained directly from the observed plasma concentration-time profiles of sitagliptin and metformin.
Measured: Pre-dose (0 hours) and multiple time points up to 48.0 hours post-dose in each period
Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-t) of Sitagliptin and Metformin
AUC0-t is calculated using the linear trapezoidal rule.
Measured: Pre-dose (0 hours) and multiple time points up to 48.0 hours post-dose in each period
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-infty) of Sitagliptin and Metformin
AUC0-infty is calculated as AUC0-t + Ct/λz, where Ct is the last quantifiable concentration and λz is the terminal elimination rate constant.
Measured: Pre-dose (0 hours) and multiple time points up to 48.0 hours post-dose in each period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Feb 202322 Mar 2023

First posted1 Jul 2026
Study start14 Feb 2023
Primary completion22 Mar 2023
Study completion22 Mar 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy VolunteersStudies of the same condition, open and under way.
More trials run by The Affiliated Hospital of Qingdao UniversityThe sponsor's other registered studies.
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: 76 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07679711
Sponsor's protocol ID: QLG1061-01
Status last verified: Jun 2026
First submitted: 24 Jun 2026
Last updated: 1 Jul 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Bioequivalence Study of Two Formulations of a Sitagliptin/Metformin Hydrochloride Extended-Release Tablet in Healthy Chinese Subjects Under Fasting and Fed Conditions: A Randomized, Open-Label, Single-Dose, Crossover Trial
ClinicalTrials.gov ID: NCT07679711
Acronym / sponsor ID: QLG1061-01
Conditions: Healthy Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 76 participants (actual)
Lead sponsor: The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
Collaborators: Qilu Pharmaceutical (Hainan) Co., Ltd.
Study start: 14 Feb 2023 (actual)
Primary completion: 22 Mar 2023 (actual)
Study completion: 22 Mar 2023 (actual)
First posted: 1 Jul 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.

The study is designed as a single-center, open-label, randomized, single-dose, two-period, two-sequence crossover trial. It consists of two separate parts: a fasting study and a fed study.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Fasting, Sequence T-R	Experimental	Drug: Sitagliptin / Metformin hydrochloride extended-release tablet (Test), Drug: Sitagliptin / Metformin hydrochloride extended-release tablet (Reference)Participants in the fasting cohort receive the test product (Sitagliptin/Metformin extended-release tablet) in Period 1, followed by a washout period of at least 5 days, and then receive the reference product (Janumet XR) in Period 2.
Fasting, Sequence R-T	Active comparator	Drug: Sitagliptin / Metformin hydrochloride extended-release tablet (Test), Drug: Sitagliptin / Metformin hydrochloride extended-release tablet (Reference)Arm Description: Participants in the fasting cohort receive the reference product (Janumet XR) in Period 1, followed by a washout period of at least 5 days, and then receive the test product (Sitagliptin/Metformin extended-release tablet) in Period 2.
Fed, Sequence T-R	Experimental	Drug: Sitagliptin / Metformin hydrochloride extended-release tablet (Test), Drug: Sitagliptin / Metformin hydrochloride extended-release tablet (Reference)Participants in the fed cohort (after a high-fat, high-calorie meal) receive the test product (Sitagliptin/Metformin extended-release tablet) in Period 1, followed by a washout period of at least 5 days, and then receive the reference product (Janumet XR) in Period 2.
Fed, Sequence R-T	Active comparator	Drug: Sitagliptin / Metformin hydrochloride extended-release tablet (Test), Drug: Sitagliptin / Metformin hydrochloride extended-release tablet (Reference)Participants in the fed cohort (after a high-fat, high-calorie meal) receive the reference product (Janumet XR) in Period 1, followed by a washout period of at least 5 days, and then receive the test product (Sitagliptin/Metformin extended-release tablet) in Period 2.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Sign the informed consent form before the trial, and fully understand the trial content, process, and possible adverse reactions.
Able to complete the study according to the requirements of the study protocol.
Subjects voluntarily agree to use effective non-pharmacological contraception methods from the signing of informed consent (14 days prior to signing for female subjects) until 3 months after the last dose, with no plans for pregnancy, sperm donation, or egg donation.
Male and female subjects aged 18 years and above.
Male subjects weighing ≥ 50.0 kg and female subjects weighing ≥ 45.0 kg; Body Mass Index (BMI) within the range of 19.0 to 27.0 kg/m^2 (inclusive).

Key exclusion criteria (23 listed)

History of specific allergies (e.g., urticaria, exfoliative dermatitis, angioedema, or bronchial hyperresponsiveness), or allergic constitution (e.g., allergic to two or more drugs, foods such as milk and pollen), or known allergy to the components or analogs of this drug.
Serious history of cardiovascular, hepatic, renal, gastrointestinal, neurological, endocrine, respiratory, or psychiatric abnormalities, which the investigator considers inappropriate for participation.
Clinically significant abnormal findings as judged by the investigator, including physical examination, vital signs, electrocardiogram, or clinical laboratory tests.
History of or current pancreatitis.
History of hypoglycemia.

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 extended-release tablet (Test)A single oral dose of sitagliptin 50 mg / metformin hydrochloride 500 mg extended-release tablet manufactured by Qilu Pharmaceutical (Hainan) Co., Ltd., administered with 240 mL of warm water.	Drug	Fasting, Sequence R-T, Fasting, Sequence T-R, Fed, Sequence R-T, Fed, Sequence T-R
Sitagliptin / Metformin hydrochloride extended-release tablet (Reference)A single oral dose of sitagliptin 50 mg / metformin hydrochloride 500 mg extended-release tablet (Janumet XR) manufactured by Merck Sharp \& Dohme Corp., administered with 240 mL of warm water.	Drug	Fasting, Sequence R-T, Fasting, Sequence T-R, Fed, Sequence R-T, Fed, Sequence T-R

Primary outcome

Maximum Observed Plasma Concentration (Cmax) of Sitagliptin and Metformin
Time frame: Pre-dose (0 hours) and multiple time points up to 48.0 hours post-dose in each period
Cmax will be obtained directly from the observed plasma concentration-time profiles of sitagliptin and metformin.
Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-t) of Sitagliptin and Metformin
Time frame: Pre-dose (0 hours) and multiple time points up to 48.0 hours post-dose in each period
AUC0-t is calculated using the linear trapezoidal rule.
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-infty) of Sitagliptin and Metformin
Time frame: Pre-dose (0 hours) and multiple time points up to 48.0 hours post-dose in each period
AUC0-infty is calculated as AUC0-t + Ct/λz, where Ct is the last quantifiable concentration and λz is the terminal elimination rate constant.

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 1 Jul 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?

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 5 inclusion and 23 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 1 Jul 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?

Maximum Observed Plasma Concentration (Cmax) of Sitagliptin and Metformin (time frame: Pre-dose (0 hours) and multiple time points up to 48.0 hours post-dose in each period). 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?

On the ClinicalTrials.gov record for NCT07679711.

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 1 Jul 2026.