Type 2 DiabetesNCT03771781
Bioequivalence Study of Empagliflozin Tablet in Healthy Participants.
A study testing Empagliflozin Tablets and Empagliflozin Tab 25 MG in people with Type 2 Diabetes, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial summary
Bioequivalence Study of Empagliflozin Tablets and Jardiance® Under Fasting and Fed Conditions in Chinese Healthy Volunteers. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Empagliflozin Tablets and Empagliflozin Tab 25 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 16 Apr 2018to 25 May 2018
- Phase
- Interventional
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female, age 18 to 50 years, inclusive.
- The body weight of male is not less than 50kg, and female is not less than 45kg. All participants' body mass index (BMI) is between 19~26.
- Subjects are fully informed and voluntarily consent to participate in this study.
- Volunteers can communicate well with researchers and comply with the requirements of this study.
Who cannot join
- Any with chronic or active gastrointestinal diseases such as esophageal diseases, gastritis, gastric ulcers, enteritis, active gastrointestinal bleeding or got any digestive tract surgery within three years.
- Any disease previously or currently suffering from circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry, and metabolic abnormalities, and which the researchers believe can interfere with the results of the test.
- Any history of allergy to drugs, food, or other substances.
- Dysphagia, difficulty in collecting blood or halo needle, history of dizziness.
- Those who have undergone surgery during the first four weeks of the trial or are scheduled to perform surgery during the study period.
- Those who has taken any drug (including vitamin products, Chinese herbs) within 14 days before the study.
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- Those who use any inhibits or induces hepatic metabolism within 30 days before the study.
- Those who participated in any clinical drug trial within 3 months prior to the trial.
- Those who donated or lose massive blood within 3 months before the study (> 450 ml).
- Pregnant and lactating women.
- Male subjects (or their partners) or female subjects had unprotected sex or pregnancy plans within 2 weeks before screening and 6 months after the end of the trial, Those who are unwilling to use one or more non-drug contraceptive methods (e. G. Complete abstinence, contraceptive ring, partner ligation, etc.) during the study.
- Drug abusers or those who have used soft drugs for 3 months before the trial or who took hard drugs one year before the study.
- Those who has special requirements for diet and is unable to follow a uniform diet.
- Smokers or those who smoked more than 5 cigarettes a day 3 months before the study.
- An alcoholic or regular drinker for six months before the study, that is, a person who drinks more than 14 units of alcohol a week.
- People who drink excessive amounts of tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup =250 mL) per day or who do not agree to stop drinking tea, coffee and/or caffeinated beverages during the study period.
- Those who take drug or food which may affect the drug metabolism(including grapefruit or grapefruit products, dragon fruit, mango, pomelo, orange, yellow purine diet).Or the researchers think that there are other affect drug absorption, distribution, metabolism and excretion of diet.Or refuse to stop eating the diet during the study.
- Those with abnormal physical examination, electrocardiogram, laboratory examination, vital signs and test related examination with clinical significance .
- Those who has vital signs with clinical significance, positive urine screening test, positive alcohol breath test or positive female urine pregnancy.
- Those who has acute illness or concomitant medication occurred before participating in the study.
- Other reasons which,in the opinion of the medical investigator,would prevent the subject from participating in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Center, Open-Label, Randomized, Single-Dose, Two-Period, Two-Sequence, Crossover Study to Assess the Bioequivalence of Test Formulation With Reference Formulation in Healthy Adult Subjects.
Bioequivalence Study of Empagliflozin Tablets and Jardiance® Under Fasting and Fed Conditions in Chinese Healthy Volunteers.
Read the detailed description
A Single-Center,Open-Label,Randomized,Single-Dose,Two-Period,Two-Sequence,Crossover Study to Assess the Bioequivalence of Test Formulation Empagliflozin Tablets with Reference Formulation Jardiance® in Chinese Healthy Adult Subjects under Fasting and Fed Conditions.
- Conditions
- Type 2 Diabetes
- Being tested
- Empagliflozin Tablets, Empagliflozin Tab 25 MG
- 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.
Empagliflozin TabletsDrug
Observe the safty and PK after subjects receiving a single dose of Empagliflozin Tablets.
Empagliflozin Tab 25 MGDrug
Observe the safty and PK after subjects receiving a single dose of Empagliflozin Tablets( Jardiance®）.
| Study group | Role | What they receive |
|---|---|---|
| Empagliflozin Tablets | Other | The test formulation is manufactured by Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd.During the study session,subjects will be administered a single does of Empagliflozin Tablets 25mg after fasting and fed conditions. Receives: Drug: Empagliflozin Tablets |
| Empagliflozin Tab 25 MG | Other | The reference formulation is manufactured by Boehringer Ingelheim International GmbH.During the study session,subjects will be administered a single does of Empagliflozin Tab 25 MG after fasting and fed conditions. Receives: Drug: Empagliflozin Tab 25 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Plasma Concentration (Cmax)
Maximum observed plasma concentration following drug administration from the raw plasma concentration-time data.
Measured: 0hours、0.67hours、1hours、1.5hours、2hours、2.5hours、3hours、4hours、6hours、8hours、12hours、24hours、36hours、48hours、72hours
Secondary outcomes (1)
Area under the plasma concentration versus time curves (AUC)
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration.
Measured: 0hours、0.67hours、1hours、1.5hours、2hours、2.5hours、3hours、4hours、6hours、8hours、12hours、24hours、36hours、48hours、72hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2018
- Study start16 Apr 2018
- Primary completion25 May 2018
- Study completion25 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03771781
- Sponsor's protocol ID
- CTTQ-BE-2018-EGLJ
- Status last verified
- Feb 2019
- First submitted
- 9 Dec 2018
- Last updated
- 21 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Open-Label, Randomized, Single-Dose, Two-Period, Two-Sequence, Crossover Study to Assess the Bioequivalence of Test Formulation With Reference Formulation in Healthy Adult Subjects.
- ClinicalTrials.gov ID
- NCT03771781
- Acronym / sponsor ID
- CTTQ-BE-2018-EGLJ
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Apr 2018 (actual)
- Primary completion
- 25 May 2018 (actual)
- Study completion
- 25 May 2018 (actual)
- First posted
- 11 Dec 2018 (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.
Bioequivalence Study of Empagliflozin Tablets and Jardiance® Under Fasting and Fed Conditions in Chinese Healthy Volunteers.
Detailed description
A Single-Center,Open-Label,Randomized,Single-Dose,Two-Period,Two-Sequence,Crossover Study to Assess the Bioequivalence of Test Formulation Empagliflozin Tablets with Reference Formulation Jardiance® in Chinese Healthy Adult Subjects under Fasting and Fed Conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Empagliflozin Tablets | Other | Drug: Empagliflozin TabletsThe test formulation is manufactured by Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd.During the study session,subjects will be administered a single does of Empagliflozin Tablets 25mg after fasting and fed conditions. |
| Empagliflozin Tab 25 MG | Other | Drug: Empagliflozin Tab 25 MGThe reference formulation is manufactured by Boehringer Ingelheim International GmbH.During the study session,subjects will be administered a single does of Empagliflozin Tab 25 MG after fasting and fed conditions. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male or female, age 18 to 50 years, inclusive.
- The body weight of male is not less than 50kg, and female is not less than 45kg. All participants' body mass index (BMI) is between 19~26.
- Subjects are fully informed and voluntarily consent to participate in this study.
- Volunteers can communicate well with researchers and comply with the requirements of this study.
Key exclusion criteria (21 listed)
- Any with chronic or active gastrointestinal diseases such as esophageal diseases, gastritis, gastric ulcers, enteritis, active gastrointestinal bleeding or got any digestive tract surgery within three years.
- Any disease previously or currently suffering from circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry, and metabolic abnormalities, and which the researchers believe can interfere with the results of the test.
- Any history of allergy to drugs, food, or other substances.
- Dysphagia, difficulty in collecting blood or halo needle, history of dizziness.
- Those who have undergone surgery during the first four weeks of the trial or are scheduled to perform surgery during the study period.
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 |
|---|---|---|
| Empagliflozin TabletsObserve the safty and PK after subjects receiving a single dose of Empagliflozin Tablets. | Drug | Empagliflozin Tablets |
| Empagliflozin Tab 25 MGObserve the safty and PK after subjects receiving a single dose of Empagliflozin Tablets( Jardiance®）. | Drug | Empagliflozin Tab 25 MG |
Primary outcome
Peak Plasma Concentration (Cmax)
Time frame: 0hours、0.67hours、1hours、1.5hours、2hours、2.5hours、3hours、4hours、6hours、8hours、12hours、24hours、36hours、48hours、72hours
Maximum observed plasma concentration following drug administration from the raw plasma concentration-time data.
1 secondary outcome
Area under the plasma concentration versus time curves (AUC)
Time frame: 0hours、0.67hours、1hours、1.5hours、2hours、2.5hours、3hours、4hours、6hours、8hours、12hours、24hours、36hours、48hours、72hours
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 21 Feb 2019.
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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?
A study testing Empagliflozin Tablets and Empagliflozin Tab 25 MG in people with Type 2 Diabetes, run by Chia Tai Tianqing Pharmaceutical Group 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 21 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 Feb 2019. 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.
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?
Peak Plasma Concentration (Cmax) (time frame: 0hours、0.67hours、1hours、1.5hours、2hours、2.5hours、3hours、4hours、6hours、8hours、12hours、24hours、36hours、48hours、72hours). 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 21 Feb 2019.