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

Atrial Fibrillation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04764201
• Other study ID #: HM-EDOX-101
• Status: Completed
• Phase: Phase 1
• Start date: January 16, 2021
• Est. completion date: March 8, 2021

Study information

• Verified date: March 2021
• Source: Hanmi Pharmaceutical Company Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 8, 2021
• Est. primary completion date: February 26, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• HIP2001
Test drug
• HGP2001
Reference drug

Locations

Country	Name	City	State
Korea, Republic of	Jeonbuk University Hospital	Jeonju

Sponsors (1)

Lead Sponsor	Collaborator
Hanmi Pharmaceutical Company Limited

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUCt	Pharmacokinetic evaluation	0~48 hours
Primary	Cmax	Pharmacokinetic evaluation	0~48 hours
Secondary	AUCinf	Pharmacokinetic evaluation	0~48 hours
Secondary	Tmax	Pharmacokinetic evaluation	0~48 hours
Secondary	t1/2	Pharmacokinetic evaluation	0~48 hours
Secondary	CL/F	Pharmacokinetic evaluation	0~48 hours
Secondary	Vd/F	Pharmacokinetic evaluation	0~48 hours