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Type 2 Diabetes MellitusPhase 1NCT05415644

Study of the Bioequivalence and Food Effects of HRX0701 Tablets in Healthy Subjects

A Phase 1 study testing hrx0701 tablets、Metformin hydrochloride tablets、Retagliptin phosphate tablets and hrx0701 tablets in people with Type 2 Diabetes Mellitus, run by Shandong Suncadia Medicine Co., Ltd. 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

To evaluate the bioequivalence of a single oral dose of HRX0701 tablets and the reference formulations retagliptin phosphate tablets and metformin hydrochloride tablets in healthy subjects in the postprandial state; To evaluate the pharmacokinetic effects of a high-fat diet on retagliptin and metformin after a single… Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
hrx0701 tablets、Metformin hydrochloride tablets、Retagliptin phosphate tablets and hrx0701 tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
78 participants
Where
1 siteChina
Study dates
5 Jul 2022to 8 Aug 2022
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

  • Male and female subjects aged 18 to 45 years (both ends of the value, subject to the signing of informed consent).
  • Male weight ≥ 50.0 kg, female weight ≥ 45.0 kg, and body mass index (BMI): 19~26 kg/m2 (including both ends).
  • Based on medical history, comprehensive physical examination, laboratory tests, 12-lead ECG, chest x-ray, vital signs, etc., the researchers determined that the subjects met the health criteria.
  • Voluntarily sign an informed consent form prior to the commencement of activities related to this trial, be able to understand the procedures and methods of this trial, and be willing to complete this trial in strict compliance with the clinical trial protocol.

Who cannot join

  • Have a history of any clinically serious disease or a disease or condition that the researcher believes may affect the results of the test, including but not limited to circulatory system, endocrine system, nervous system, digestive system, urinary system or blood, immune, psychiatric and metabolic disease history.
  • People with allergies, including those who are explicitly allergic to the research drug or any ingredient in the research drug, allergic to any food ingredients or have special requirements for diet, and cannot comply with the unified diet.
  • Those who have undergone any surgery within 3 months before screening, or who have not recovered after surgery, or who may have surgery or hospitalization plans during the estimated trial period.
  • Have taken any prescription drugs, over-the-counter drugs, Chinese herbal medicines or dietary supplements within 2 weeks before the screening period;
  • Those who have consumed grapefruit or fruit juice products within 2 days before administration, any food or beverage containing caffeine (such as coffee, tea, chocolate, cola or other carbonated drinks containing caffeine, etc.), xanthine foods or alcohol.
  • The researcher determines that the subject has a medical condition that affects the absorption, distribution, metabolism and excretion of the drug or can reduce compliance or the researcher deems inappropriate.
Show all 17Show fewer
  • Screening those who have participated in clinical trials of any drug or medical device within 3 months before screening.
  • Those who donated blood (or lost blood) within 3 months before screening and donated blood (or lost blood) ≥ 400 mL, or received blood transfusions.
  • Those who plan to receive live (attenuated) vaccines during the trial.
  • Have a birth plan at the end of the screening to follow-up period, or refuse to use medically approved contraception.
  • Smokers (average of 5 cigarettes or more per day).
  • An average daily intake of more than 25 g of alcohol in the 1 month prior to screening (e.g., 750 mL of beer, 250 mL of wine, or 50 mL of low-grade liquor);
  • Drug abusers or drug urine screening test positive.
  • Positive for hepatitis B surface antigen (HBsAg) within 1 month before screening or screening period, or positive for anti-hepatitis C virus (HCV), or positive for human immunodeficiency virus (HIV), or positive for syphilis antibody.
  • 12-lead electrocardiogram (ECG) shows abnormalities and is of clinical significance.
  • There are any abnormal laboratory test values that are clinically significant by the researchers; (Note: For abnormal laboratory tests with clinical significance, if there is a clear and reasonable reason, the retest can be retested within one week, and the retest results can be used to determine whether the subject meets the conditions).
  • Subjects may not be able to complete this study for other reasons or those whom the researchers believe should not be included.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Xiangya Third Hospital

    Changsha, Hunan, 410013

Other trials in China

About this study

To evaluate the bioequivalence of a single oral dose of HRX0701 tablets and the reference formulations retagliptin phosphate tablets and metformin hydrochloride tablets in healthy subjects in the postprandial state; To evaluate the pharmacokinetic effects of a high-fat diet on retagliptin and metformin after a single oral administration of HRX0701 tablets in healthy subjects.

Being tested
hrx0701 tablets、Metformin hydrochloride tablets、Retagliptin phosphate tablets, hrx0701 tablets
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

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

  • hrx0701 tablets、Metformin hydrochloride tablets、Retagliptin phosphate tabletsDrug

    High-specification group: subject preparation: HRX0701 (50 mg/1000 mg) 1 tablet (to be taken after a meal); Reference preparation: 1 tablet of retagliptin phosphate (50 mg), 2 tablets of metformin hydrochloride (Glucophage®) (500 mg), taken twice after meals.

    Low Specification Group:

    Preparation: HRX0701 (50 mg/850 mg) 1 tablet (taken after a meal); Reference: 1 tablet of retagliptin phosphate (50 mg), 1 tablet of metformin hydrochloride (Glucophage®) (850 mg), taken twice after meals.

  • hrx0701 tabletsDrug

    High specification group HRX0701 (FDC) tablets (50 mg / 1000 mg) for a total of 2 tablets (take 1 tablet after meals or on an empty stomach).

    Low-spec group HRX0701 (FDC) tablets (50 mg / 850 mg) for a total of 2 tablets (take 1 tablet after meals or on an empty stomach).

Study groups in NCT05415644
Study groupRoleWhat they receive
Bioequivalence study partExperimentalNot described
Receives: Drug: hrx0701 tablets、Metformin hydrochloride tablets、Retagliptin phosphate tablets
Food impact study partExperimentalNot described
Receives: Drug: hrx0701 tablets

What is being measured

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

  1. PK parameters Cmax, in the postprandial plasma of subjects in postprandial plasma

    Measured: day 1 to day 18

  2. PK parameters AUC0-t in the postprandial plasma of subjects in postprandial plasma

    Measured: day 1 to day 18

  3. PK parameters AUC0-∞ in the postprandial plasma of subjects in postprandial plasma

    Measured: day 1 to day 18

  4. The PK parameters of retagliptin and metformin in the blood plasma on fasting and after meals reach peak time (Tmax)

    Measured: day 1 to day 18

  5. The PK parameters of retagliptin and metformin in the blood plasma on fasting and after meals peak concentration (Cmax)

    Measured: day 1 to day 18

  6. The PK parameters of retagliptin and metformin in the blood plasma on fasting and after meals area under the drug-time curve (AUC0-t)

    Measured: day 1 to day 18

  7. The PK parameters of retagliptin and metformin in the blood plasma on fasting and after meals area under the drug-time curve (AUC0-∞)

    Measured: day 1 to day 18

Secondary outcomes (8)

  1. Apparent distribution volume (Vz/F)

    Measured: day 1 to day 18

  2. apparent clearance (CL/F)

    Measured: day 1 to day 18

  3. terminal phase half-life (t1/2)

    Measured: day 1 to day 18

  4. retagliptin and metformin in plasma on fasting and after meals

    Measured: day 1 to day 18

  5. The main metabolites of retagliptin acid PK parameters Cmax

    Measured: day 1 to day 18

  6. The main metabolites of retagliptin acid AUC0-t

    Measured: day 1 to day 18

  7. The main metabolites of retagliptin acid AUC0-∞

    Measured: day 1 to day 18

  8. Adverse events

    Measured: day 1 to day 25

Timeline

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

  1. First posted13 Jun 2022
  2. Study start5 Jul 2022
  3. Primary completion8 Aug 2022
  4. Study completion8 Aug 2022

Resources

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
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
HRX0701 tablets are used alone, or Retagliptin phosphate tablets are used in combination with metformin hydrochloride tablets.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
78 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05415644
Sponsor's protocol ID
HRX0701-101
Status last verified
Dec 2022
First submitted
8 Jun 2022
Last updated
21 Dec 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing hrx0701 tablets、Metformin hydrochloride tablets、Retagliptin phosphate tablets and hrx0701 tablets in people with Type 2 Diabetes Mellitus, run by Shandong Suncadia Medicine Co., Ltd. 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 17 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 21 Dec 2022. 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?

PK parameters Cmax, in the postprandial plasma of subjects in postprandial plasma (time frame: day 1 to day 18). The study lists 7 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 NCT05415644.

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 21 Dec 2022.

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