Healthy Clinical Trial
Official title:
A Phase 1 Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic Characteristics After Administration of DWP16001 Drug A and DWP16001 Drug B in Healthy Adult Volunteers
Verified date | June 2022 |
Source | Daewoong Pharmaceutical Co. LTD. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To compare and evaluate the safety and pharmacokinetic characteristics after administration of DWP16001 Drug A and DWP16001 Drug B in healthy adult volunteers
Status | Completed |
Enrollment | 38 |
Est. completion date | August 1, 2021 |
Est. primary completion date | August 1, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 19 Years and older |
Eligibility | Inclusion Criteria: - Healthy adult volunteers aged = 19 years at screening - Subjects with a body weight of = 50.0 kg to = 90.0 kg with a body mass index (BMI) of = 18.0 kg/m2 and = 30.0 kg/m2 - Subjects with no congenital or chronic disease that requires treatment, and no clinical symptoms or findings based on medical examination - Subjects who are determined eligible to participate in this study based on results of laboratory tests, vital signs, physical examination etc at screening. Exclusion Criteria: - Current or history of clinically significant hepatic, renal, nervous, respiratory, endocrine, hemato-oncology, cardiovascular, urogenital, psychosis disorder - Current or history of gastrointestinal disorders or prior history of gastrointestinal surgery that may affect safety and PK/PD assessment of the study drug - Clinical laboratory test values are outside the accepted normal range at screening - Other exclusive inclusion criteria, as defined in the protocol |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | CHA Bundang Medical Center, CHA University | Seongnam-si | Gyeonggi-do |
Lead Sponsor | Collaborator |
---|---|
Daewoong Pharmaceutical Co. LTD. |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | AUC0_t of DWP16001 | Area under the plasma concentration versus time curve | 0-72 hours | |
Primary | Cmax of DWP16001 | Peak Plasma Concetration | 0-72 hours | |
Secondary | Tmax Tmax | Time at Cmax Tmax | 0-72 hours | |
Secondary | AUC of DWP16001 | Area under the plasma concentration versus time curve | 0-72 hours | |
Secondary | T 1/2 of DWP16001 | half life of DWP16001 | 0-72 hours | |
Secondary | CL/F of DWP16001 | Apparent total clearance of the drug from plasma after oral administration | 0-72 hours | |
Secondary | Vd/F of DWP16001 | Volume of distribution | 0-72 hours |
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