Bioequivalence Study of Empagliflozin Tablet in Healthy Participants.
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.
1 other identifier
interventional
48
1 country
1
Brief Summary
Bioequivalence Study of Empagliflozin Tablets and Jardiance® Under Fasting and Fed Conditions in Chinese Healthy Volunteers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable type-2-diabetes
Started Apr 2018
Shorter than P25 for not_applicable type-2-diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 16, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 25, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 25, 2018
CompletedFirst Submitted
Initial submission to the registry
December 9, 2018
CompletedFirst Posted
Study publicly available on registry
December 11, 2018
CompletedFebruary 21, 2019
February 1, 2019
1 month
December 9, 2018
February 20, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Peak Plasma Concentration (Cmax)
Maximum observed plasma concentration following drug administration from the raw plasma concentration-time data.
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)
0hours、0.67hours、1hours、1.5hours、2hours、2.5hours、3hours、4hours、6hours、8hours、12hours、24hours、36hours、48hours、72hours
Study Arms (2)
Empagliflozin Tablets
OTHERThe 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
OTHERThe 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.
Interventions
Observe the safty and PK after subjects receiving a single dose of Empagliflozin Tablets.
Observe the safty and PK after subjects receiving a single dose of Empagliflozin Tablets( Jardiance®）.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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.
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Third Hospital of Changsha
Changsha, Hunan, 410000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 9, 2018
First Posted
December 11, 2018
Study Start
April 16, 2018
Primary Completion
May 25, 2018
Study Completion
May 25, 2018
Last Updated
February 21, 2019
Record last verified: 2019-02