A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HGP1602 in Healthy Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: HGP1812; Drug: HGP1602

• Registration Number: NCT04084184
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

Brief Summary

An open-label, randomized, single-dose crossover study to evaluate the pharmacokinetics, safety and tolerability of HGP1602 in healthy subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-15
• Primary Completion: 2019-03-25
• Study Completion: 2019-03-29
• Status Verified: 2019-09
• Study First Submitted: 2019-09-09
• Study First Submitted QC: 2019-09-09
• Last Update Submitted: 2019-09-09
• Study First Posted: 2019-09-10
• Last Update Posted: 2019-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence 1	HGP1812	Period 1 : Fasted state + HGP1812, Period 2 : Fasted state + HGP1602
Sequence 1	HGP1602	Period 1 : Fasted state + HGP1812, Period 2 : Fasted state + HGP1602
Sequence 2	HGP1812	Period 1 :Fasted state + HGP1602, Period 2 : Fasted state + HGP1812
Sequence 2	HGP1602	Period 1 :Fasted state + HGP1602, Period 2 : Fasted state + HGP1812

Primary Outcome Measures

Name	Time	Method
AUClast of Dapagliflozin	pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour	pharmacokinetic evaluation
Cmax of Dapagliflozin	pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour	pharmacokinetic evaluation

Secondary Outcome Measures

Name	Time	Method
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	pharmacokinetic evaluation
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	pharmacokinetic evaluation
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	pharmacokinetic evaluation
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	pharmacokinetic evaluation
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	pharmacokinetic evaluation

Trial Locations

Locations (1)

Korea University Anam Hospital; 🇰🇷 Seoul, Korea, Republic of