Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a randomized, open-label, two-cycle clinical study to evaluate the drug interaction, food effect and pharmacokinetics of IBI351 and esomeprazole in healthy subjects. A total of two cohorts were planned to be enrolled in each cohort. Cohort 1: This cohort investigated the effect of esomeprazole on the pharmacokinetics of IBI351 in healthy subjects. Cohort 2: This cohort investigated the effect of food on the pharmacokinetics of IBI351 in healthy subjects.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IBI351 | Other | This cohort investigated the effect of food on the pharmacokinetics of IBI351 in healthy subjects. In a double-crossover design, subjects were enrolled and randomly divided into two test groups A and B. Group A: IBI351 was orally administered to subjects in this group on an empty stomach on Day 1, followed by a high-fat meal on Day 4. Group B: IBI351 was orally administered to subjects in this group after a high-fat meal on Day 1 followed by an empty stomach on Day 4. |
|
| IBI351+Esomeprazole | Other | Enrolled subjects were orally administered IBI351 with recommended dose on an empty stomach. Esomeprazole were administered orally. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBI351 | Drug | IBI351 is administered orally |
| |
| Measure | Description | Time Frame |
|---|---|---|
| maximum concentrations (Cmax ) for plasma | approximately 10 days after first dose | |
| area under the curve from time 0 to infinity(AUC0-inf) for plasma | approximately 10 days after first dose | |
| area under the curve from time 0 to the last time point (AUC0-t) for plasma | approximately 10 days after first dose |
| Measure | Description | Time Frame |
|---|---|---|
| time-to-maximum concentration (Tmax) for total plasma | approximately 10 days after first dose | |
| half-life (t1/2) for total plasma | approximately 10 days after first dose | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the First Affiliated Hospital of Suzhou University | Suzhou | Jiangsu | 215006 | China |
Not provided
| ID | Term |
|---|---|
| D064098 | Esomeprazole |
| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Esomeprazole |
| Drug |
Esomeprazole is administered orally |
|
| apparent clearance (CL/F) for total plasma |
| approximately 10 days after first dose |
| the time prior to the first measurable (non-zero) concentration (tlag) | approximately 10 days after first dose |
| apparent volume of distribution(Vz/F) for total plasma | approximately 10 days after first dose |
| adverse events | approximately 10 days after first dose |
| number of participants with abnormal ECG readings | approximately 10 days after first dose |
| number of participants with abnormal hematology test results | approximately 10 days after first dose |
| number of participants with abnormal chemisty test results | approximately 10 days after first dose |
| number of participants with abnormal vital signs | approximately 10 days after first dose |
| number of participants with abnormal physical examination | approximately 10 days after first dose |
| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |