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

Phase 1

Completed

• Conditions: Atrial Fibrillation
• Interventions: Drug: HIP2001; Drug: HGP2001

• Registration Number: NCT04764201
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-16
• Study First Submitted: 2021-02-15
• Study First Submitted QC: 2021-02-18
• Study First Posted: 2021-02-21
• Primary Completion: 2021-02-26
• Status Verified: 2021-03
• Study Completion: 2021-03-08
• Last Update Submitted: 2021-03-30
• Last Update Posted: 2021-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence 2	HGP2001	Period 1: HIP2001, Period 2: HGP2001
Sequence 1	HGP2001	Period 1: HGP2001, Period 2: HIP2001
Sequence 1	HIP2001	Period 1: HGP2001, Period 2: HIP2001
Sequence 2	HIP2001	Period 1: HIP2001, Period 2: HGP2001

Primary Outcome Measures

Name	Time	Method
AUCt	0~48 hours	Pharmacokinetic evaluation
Cmax	0~48 hours	Pharmacokinetic evaluation

Secondary Outcome Measures

Name	Time	Method
CL/F	0~48 hours	Pharmacokinetic evaluation
AUCinf	0~48 hours	Pharmacokinetic evaluation
Tmax	0~48 hours	Pharmacokinetic evaluation
t1/2	0~48 hours	Pharmacokinetic evaluation
Vd/F	0~48 hours	Pharmacokinetic evaluation

Trial Locations

Locations (1)

Jeonbuk University Hospital; 🇰🇷 Jeonju, Korea, Republic of