A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HGP1602 in Healthy Subjects
An Open-label, Randomized, Single-dose Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HGP1602 in Healthy Subjects
1 other identifier
interventional
28
1 country
1
Brief Summary
An open-label, randomized, single-dose crossover study to evaluate the pharmacokinetics, safety and tolerability of HGP1602 in healthy subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy
Started Mar 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 25, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 29, 2019
CompletedFirst Submitted
Initial submission to the registry
September 9, 2019
CompletedFirst Posted
Study publicly available on registry
September 10, 2019
CompletedSeptember 10, 2019
September 1, 2019
10 days
September 9, 2019
September 9, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
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
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
Secondary Outcomes (5)
AUCinf of Dapagliflozin
pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour
Tmax of Dapagliflozin
pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour
t1/2 of Dapagliflozin
pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour
CL/F of Dapagliflozin
pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour
Vd/F of Dapagliflozin
pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour
Study Arms (2)
Sequence 1
EXPERIMENTALPeriod 1 : Fasted state + HGP1812, Period 2 : Fasted state + HGP1602
Sequence 2
EXPERIMENTALPeriod 1 :Fasted state + HGP1602, Period 2 : Fasted state + HGP1812
Interventions
Eligibility Criteria
You may qualify if:
- Age 19\~45 years in healthy volunteers
- BMI is more than 18.5 kg/m\^2 , no more than 29.9 kg/m\^2
- 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
You may not qualify if:
- 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
- Subjects who judged ineligible by the investigator
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Korea University Anam Hospital
Seoul, South Korea
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2019
First Posted
September 10, 2019
Study Start
March 15, 2019
Primary Completion
March 25, 2019
Study Completion
March 29, 2019
Last Updated
September 10, 2019
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will not share