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The Pharmacokinetic Characteristics and Safety Between HIP2001 and HGP2001 in Healthy Volunteers

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: NCT04764201
Recruitment Status : Completed
First Posted : February 21, 2021
Last Update Posted : April 1, 2021
Sponsor:
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited

Study Description
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Brief Summary:
The purpose of this study is to evaluate the pharmacokinetic characteristics and safety between HIP2001 and HGP2001 in healthy volunteers.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Drug: HIP2001 Drug: HGP2001 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open Label, Single Dose, 2-way Crossover Clinical Trial to Evaluate the Pharmacokinetic Characteristics and Safety Between HIP2001 and HGP2001 in Healthy Volunteers
Actual Study Start Date : January 16, 2021
Actual Primary Completion Date : February 26, 2021
Actual Study Completion Date : March 8, 2021

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Arms and Interventions
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Arm Intervention/treatment
Sequence 1
Period 1: HGP2001, Period 2: HIP2001
 Drug: HIP2001
Test drug

Drug: HGP2001
Reference drug
Sequence 2
Period 1: HIP2001, Period 2: HGP2001
 Drug: HIP2001
Test drug

Drug: HGP2001
Reference drug


Outcome Measures
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Primary Outcome Measures :
  1. AUCt [ Time Frame: 0~48 hours ]
    Pharmacokinetic evaluation

  2. Cmax [ Time Frame: 0~48 hours ]
    Pharmacokinetic evaluation


Secondary Outcome Measures :
  1. AUCinf [ Time Frame: 0~48 hours ]
    Pharmacokinetic evaluation

  2. Tmax [ Time Frame: 0~48 hours ]
    Pharmacokinetic evaluation

  3. t1/2 [ Time Frame: 0~48 hours ]
    Pharmacokinetic evaluation

  4. CL/F [ Time Frame: 0~48 hours ]
    Pharmacokinetic evaluation

  5. Vd/F [ Time Frame: 0~48 hours ]
    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:

  • 19 kg/m^2 ≤ BMI < 28 kg/m^2, weight >60kg
  • 90 mmHg ≤ SBP <140 mmHg, 50 mmHg ≤ DBP <900 mmHg
  • agrees that the person, spouse, or partner uses appropriate medically recognized contraception and does not provide sperm or eggs from the date of administration of the first investigational drug to 7 days after the administration of the last investigational drug.

Exclusion Criteria:

  • A history of hypersensitivity reactions or clinically significant hypersensitivity reactions
  • A history of gastrointestinal diseases or surgery that may affect the absorption of clinical trial drugs
  • A history of substance abuse or who test positive for drugs of concern for abuse in the urine drug screening test
  • Positive results of serological tests
  • Have taken other investigational drugs or bioequivalence drugs within 6 months before the first administration of the investigational drug
  • Donated whole blood within 60 days prior to the screening date or donated components within 30 days or received a blood transfusion within 30 days
  • Have drank more than 210 g/week of alcohol within 30 days before the screening date
  • Have smoked more than 10 bills/day within 30 days before the screening date
  • AST, ALT value is more than 2 times the UNL or bilirubin level is more than 1.5 times the UNL, eGFR < 50 mL/min/1.73m2, Prothrombin (INR) > 1.31 INR or aPTT > 39.7 sec
  • 12-ECG QTc >450 ms
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): NCT04764201


Locations
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Korea, Republic of
Jeonbuk University Hospital
Jeonju, Korea, Republic of
Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited
Investigators
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Principal Investigator: Mingeul Kim Jeonbuk University Hospital
More Information
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Responsible Party: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT04764201    
Other Study ID Numbers: HM-EDOX-101
First Posted: February 21, 2021    Key Record Dates
Last Update Posted: April 1, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes