Status:
COMPLETED
The Pharmacokinetic Characteristics and Safety Between HIP2001 and HGP2001 in Healthy Volunteers
Lead Sponsor:
Hanmi Pharmaceutical Company Limited
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
19-45 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the pharmacokinetic characteristics and safety between HIP2001 and HGP2001 in healthy volunteers.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 8 2021
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04764201
Start Date
January 16 2021
End Date
March 8 2021
Last Update
April 1 2021
Active Locations (1)
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1
Jeonbuk University Hospital
Jeonju, South Korea