A Study to Evaluate the Drug-drug Interaction and Safety of RLD2301 and RLD2007 in Healthy Volunteers

Healthy Volunteers Clinical Trial

Official title:

An Open Label, Multiple Dose, Crossover Clinical Trial to Evaluate the Drug-drug Interaction and Safety of RLD2301 and RLD2007 After Oral Administration in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05862090
• Other study ID #: HM-ENSEMBLE-101
• Status: Completed
• Phase: Phase 1
• Start date: April 5, 2023
• Est. completion date: May 26, 2023

Study information

• Verified date: September 2023
• 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 drug-drug interaction and safety of RLD2301 and RLD2007 after oral administration in healthy volunteers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 26, 2023
• Est. primary completion date: May 26, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 54 Years

Eligibility

Inclusion Criteria:

• Age 19~54 years in healthy volunteers

• 18.5 kg/m^2 = BMI < 30 kg/m^2, weight(men) =55kg / weight(women) =45kg

• 90 mmHg = SBP <140 mmHg, 50 mmHg = DBP <90 mmHg

• Subjects who voluntarily decides to participate in this clinical trial and agree in writing to ensure compliance with the clinical trial

Exclusion Criteria:

• Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system

• Subjects who judged ineligible by the investigator

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• RLD2301
Take it once a day per period.
• RLD2007
Take it once a day per period.

Locations

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

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
Other	Change of Blood Pressure(SBP/DBP) from baseline	Pharmacodynamic evaluation	Predose at Day1 and 0~24 hours after final dose administration of each period
Other	Change of pulse rate from baseline	Pharmacodynamic evaluation	Predose at Day1 and 0~24 hours after final dose administration of each period
Other	Change of blood glucose from baseline	Pharmacodynamic evaluation	Predose at Day1 and 0~24 hours after final dose administration of each period
Other	AUECtau of Blood Pressure(SBP/DBP)	Pharmacodynamic evaluation	Predose at Day1 and 0~24 hours after final dose administration of each period
Other	AUECtau of pulse rate	Pharmacodynamic evaluation	Predose at Day1 and 0~24 hours after final dose administration of each period
Other	AUECtau of blood glucose	Pharmacodynamic evaluation	Predose at Day1 and 0~24 hours after final dose administration of each period
Other	Emax of Blood Pressure(SBP/DBP)	Pharmacodynamic evaluation	Predose at Day1 and 0~24 hours after final dose administration of each period
Other	Emax of pulse rate	Pharmacodynamic evaluation	Predose at Day1 and 0~24 hours after final dose administration of each period
Other	Emax of blood glucose	Pharmacodynamic evaluation	Predose at Day1 and 0~24 hours after final dose administration of each period
Primary	AUCtau	Pharmacokinetic evaluation	0~24 hours after final dose administration
Primary	Css,max	Pharmacokinetic evaluation	0~24 hours after final dose administration
Secondary	Css,min	Pharmacokinetic evaluation	0~24 hours after final dose administration
Secondary	Css,av	Pharmacokinetic evaluation	0~24 hours after final dose administration
Secondary	Tss,max	Pharmacokinetic evaluation	0~24 hours after final dose administration
Secondary	t1/2	Pharmacokinetic evaluation	0~24 hours after final dose administration
Secondary	CLss/F	Pharmacokinetic evaluation	0~24 hours after final dose administration
Secondary	Vdss/F	Pharmacokinetic evaluation	0~24 hours after final dose administration
Secondary	Fluctuation[(Css,max-Css,min)/Css,av]	Pharmacokinetic evaluation	0~24 hours after final dose administration
Secondary	Swing[(Css,max-Css,min)/Css,min]	Pharmacokinetic evaluation	0~24 hours after final dose administration