| Trial ID: | L2613 |
| Source ID: | NCT05415644
|
| Associated Drug: |
Hrx0701 Tablets、Metformin Hydrochloride Tablets、Retagliptin Phosphate Tablets
|
| Title: |
Study of the Bioequivalence and Food Effects of HRX0701 Tablets in Healthy Subjects
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: hrx0701 tablets、Metformin hydrochloride tablets、Retagliptin phosphate tablets|DRUG: hrx0701 tablets
|
| Outcome Measures: |
Primary: PK parameters Cmax, in the postprandial plasma of subjects in postprandial plasma, day 1 to day 18|PK parameters AUC0-t in the postprandial plasma of subjects in postprandial plasma, day 1 to day 18|PK parameters AUC0-∞ in the postprandial plasma of subjects in postprandial plasma, day 1 to day 18|The PK parameters of retagliptin and metformin in the blood plasma on fasting and after meals reach peak time (Tmax), day 1 to day 18|The PK parameters of retagliptin and metformin in the blood plasma on fasting and after meals peak concentration (Cmax), day 1 to day 18|The PK parameters of retagliptin and metformin in the blood plasma on fasting and after meals area under the drug-time curve (AUC0-t), day 1 to day 18|The PK parameters of retagliptin and metformin in the blood plasma on fasting and after meals area under the drug-time curve (AUC0-∞), day 1 to day 18 | Secondary: Apparent distribution volume (Vz/F), day 1 to day 18|apparent clearance (CL/F), day 1 to day 18|terminal phase half-life (t1/2), day 1 to day 18|retagliptin and metformin in plasma on fasting and after meals, day 1 to day 18|The main metabolites of retagliptin acid PK parameters Cmax, day 1 to day 18|The main metabolites of retagliptin acid AUC0-t, day 1 to day 18|The main metabolites of retagliptin acid AUC0-∞, day 1 to day 18|Adverse events, day 1 to day 25
|
| Sponsor/Collaborators: |
Sponsor: Shandong Suncadia Medicine Co., Ltd.
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
78
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2022-07-05
|
| Completion Date: |
2022-08-08
|
| Results First Posted: |
|
| Last Update Posted: |
2022-12-21
|
| Locations: |
Xiangya Third Hospital, Changsha, Hunan, 410013, China
|
| URL: |
https://clinicaltrials.gov/show/NCT05415644
|
