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

• Sponsor: Hanmi Pharmaceutical Company Limited (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04084184
• Collaborator: (none)
• Enrollment: 28
• Location: 1
• Arms: 2
• Actual Duration (Days): 14
• Patients Per Site Per Month: 60.9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: HGP1812; Drug: HGP1602	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 28 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-label, Randomized, Single-dose Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HGP1602 in Healthy Subjects
• Actual Study Start Date: Mar 15, 2019
• Actual Primary Completion Date: Mar 25, 2019
• Actual Study Completion Date: Mar 29, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sequence 1 Period 1 : Fasted state + HGP1812, Period 2 : Fasted state + HGP1602	Drug: HGP1812; Dapagliflozin (Forxiga) 10mg; Drug: HGP1602; Dapagliflozin 10mg
Experimental: Sequence 2 Period 1 :Fasted state + HGP1602, Period 2 : Fasted state + HGP1812	Drug: HGP1812; Dapagliflozin (Forxiga) 10mg; Drug: HGP1602; Dapagliflozin 10mg

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

Secondary Outcome Measures

1. 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

2. 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

3. 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

4. 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

5. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Korea University Anam Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• Hanmi Pharmaceutical Company Limited

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hanmi Pharmaceutical Company Limited
• ClinicalTrials.gov Identifier: NCT04084184
• Other Study ID Numbers: HM-DAPA-101
• First Posted: Sep 10, 2019
• Last Update Posted: Sep 10, 2019
• Last Verified: Sep 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Sep 10, 2019