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To study the pharmacokinetics of test preparation and reference preparation irbesartan tablets (0.15g/tablet) in a single oral administration in fasting and fed state,respectively, in healthy adult subjects, and to evaluate the bioequivalence of the two preparations
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Reference formulation | Experimental | Irbesartan tablet (0.15g/tablet) , Manufacturer: Sanofi Winthrop Industries |
|
| Experimental: Test formulation | Experimental | Irbesartan tablet (0.15g/tablet) , Manufacturer: Zhejiang Hua Hai Pharmaceutical Co. LTD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Irbesartan Tablet | Drug | Drug: Irbesartan Oral administration on an empty stomach/fed condition |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-t | Pharmacokinetic parameter AUC0-t estimated by non-compartmental analysis model based on the plasma concentration data of concentration data of irbesartan | up to 1 year |
| AUC0-∞ | Pharmacokinetic parameter AUC0-∞ estimated by non-compartmental analysis model based on the plasma concentration data of concentration data of irbesartan | up to 1 year |
| Cmax | Pharmacokinetic parameter Cmax estimated by non-compartmental analysis model based on the plasma concentration data of concentration data of irbesartan | up to 1 year |
| Tmax | Pharmacokinetic parameter Tmax estimated by non-compartmental analysis model based on the plasma concentration data of concentration data of irbesartan | up to 1 year |
| bioequivalence | Analysis of variance (ANOVA) was performed after logarithmic conversion of main pharmacokinetic parameters (Cmax, AUC) to calculate 90% confidence interval of geometric mean ratio of main pharmacokinetic parameters of the two preparations, and equivalence comparison was conducted. The equivalent interval was set to 80.00%~125.00% | up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE | Number of participants with treatment-related adverse events as assessed by CTCAE | up to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yu Cao, professor | Contact | 86-18661809090 | caoyu1767@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Yu Cao, professor | The Affiliated Hospital of Qingdao University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Hospital of Qingdao University | Recruiting | Qingdao | Shandong | 266000 | China |
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| ID | Term |
|---|---|
| D000077405 | Irbesartan |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D013141 | Spiro Compounds |
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |