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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04764201

Enrollment

Registered

2021-02-21

Start date

2021-01-16

Completion date

2021-03-08

Last updated

2021-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Brief summary

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

Interventions

DRUGHIP2001

Test drug

DRUGHGP2001

Reference drug

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
AUCt	0~48 hours	Pharmacokinetic evaluation
Cmax	0~48 hours	Pharmacokinetic evaluation

Secondary

Measure	Time frame	Description
t1/2	0~48 hours	Pharmacokinetic evaluation
AUCinf	0~48 hours	Pharmacokinetic evaluation
Vd/F	0~48 hours	Pharmacokinetic evaluation
CL/F	0~48 hours	Pharmacokinetic evaluation
Tmax	0~48 hours	Pharmacokinetic evaluation

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026