Healthy Clinical Trial
Official title:
An Open-label, Randomized, Single-dose Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HCP1801 in Healthy Subjects
Verified date | July 2022 |
Source | Hanmi Pharmaceutical Company Limited |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
An open-label, randomized, single-dose crossover study to evaluate the pharmacokinetics, safety and tolerability of HCP1801 in healthy subjects.
Status | Completed |
Enrollment | 85 |
Est. completion date | April 16, 2019 |
Est. primary completion date | March 25, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 19 Years to 45 Years |
Eligibility | Inclusion Criteria: 1. Age 19~45 years in healthy volunteers 2. BMI is more than 18.5 kg/m^2 , no more than 29.9 kg/m^2 3. Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing Exclusion Criteria: 1. Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system 2. Subjects who judged ineligible by the investigator |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Kyungpook National University Hospital | Daegu |
Lead Sponsor | Collaborator |
---|---|
Hanmi Pharmaceutical Company Limited |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cmax of Dapagliflozin | pharmacokinetic evaluation | pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour | |
Primary | AUClast of Dapagliflozin | pharmacokinetic evaluation | pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour | |
Primary | Cmax of Metformin | pharmacokinetic evaluation | pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour | |
Primary | AUClast of Metformin | pharmacokinetic evaluation | pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour | |
Secondary | AUCinf of Dapagliflozin | pharmacokinetic evaluation | pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour | |
Secondary | Tmax of Dapagliflozin | pharmacokinetic evaluation | pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour | |
Secondary | t1/2 of Dapagliflozin | pharmacokinetic evaluation | pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour | |
Secondary | CL/F of Dapagliflozin | pharmacokinetic evaluation | pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour | |
Secondary | Vd/F of Dapagliflozin | pharmacokinetic evaluation | pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour | |
Secondary | AUCinf of Metformin | pharmacokinetic evaluation | pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour | |
Secondary | Tmax of Metformin | pharmacokinetic evaluation | pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour | |
Secondary | t1/2 of Metformin | pharmacokinetic evaluation | pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour | |
Secondary | CL/F of Metformin | pharmacokinetic evaluation | pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour | |
Secondary | Vd/F of Metformin | pharmacokinetic evaluation | pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour |
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