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A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HCP1801 in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03826641
Recruitment Status : Unknown
Verified January 2019 by Hanmi Pharmaceutical Company Limited.
Recruitment status was:  Recruiting
First Posted : February 1, 2019
Last Update Posted : February 1, 2019
Sponsor:
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited

Study Description
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Brief Summary:
An open-label, randomized, single-dose crossover study to evaluate the pharmacokinetics, safety and tolerability of HCP1801 in healthy subjects.

Condition or disease Intervention/treatment Phase
Healthy Drug: HCP1805 Drug: HCP1801 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 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 HCP1801 in Healthy Subjects
Estimated Study Start Date : February 15, 2019
Estimated Primary Completion Date : March 18, 2019
Estimated Study Completion Date : March 18, 2019
Arms and Interventions
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Arm Intervention/treatment
Experimental: Sequence 1
Period 1 : Fasted state + HCP1805, Period 2 : Fasted state + HCP1801
 Drug: HCP1805
Dapagliflozin/Metformin (Xigduo XR) 10/1000mg

Drug: HCP1801
Dapagliflozin/Metformin 10/1000mg
Experimental: Sequence 2
Period 1 : Fasted state + HCP1801, Period 2 : Fasted state + HCP1805
 Drug: HCP1805
Dapagliflozin/Metformin (Xigduo XR) 10/1000mg

Drug: HCP1801
Dapagliflozin/Metformin 10/1000mg
Experimental: Sequence 3
Period 1 : High fat diet + HCP1805, Period 2 : High fat diet + HCP1801
 Drug: HCP1805
Dapagliflozin/Metformin (Xigduo XR) 10/1000mg

Drug: HCP1801
Dapagliflozin/Metformin 10/1000mg
Experimental: Sequence 4
Period 1 : High fat diet + HCP1801, Period 2 : High fat diet + HCP1805
 Drug: HCP1805
Dapagliflozin/Metformin (Xigduo XR) 10/1000mg

Drug: HCP1801
Dapagliflozin/Metformin 10/1000mg


Outcome Measures
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Primary Outcome Measures :
  1. Cmax of Dapagliflozin [ Time Frame: 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 [ Time Frame: 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. Cmax of Metformin [ Time Frame: 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. AUClast of Metformin [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour ]
    pharmacokinetic evaluation

  6. AUCinf of Metformin [ Time Frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour ]
    pharmacokinetic evaluation

  7. Tmax of Metformin [ Time Frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour ]
    pharmacokinetic evaluation

  8. t1/2 of Metformin [ Time Frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour ]
    pharmacokinetic evaluation

  9. CL/F of Metformin [ Time Frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour ]
    pharmacokinetic evaluation

  10. Vd/F of Metformin [ Time Frame: 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
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Ages Eligible for Study:   19 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03826641


Contacts
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Contact: Yirang Lim 02-410-0339 yirang.lim@hanmi.co.kr

Locations
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Korea, Republic of
Kyungpook National University Hospital Recruiting
Daegu, Korea, Republic of
Contact: Young-Ran Yoon, M.D       yry@knu.ac.kr   
Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited
More Information
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Responsible Party: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT03826641    
Other Study ID Numbers: HM-DAME-101
First Posted: February 1, 2019    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No