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

• Sponsor: Hanmi Pharmaceutical Company Limited (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05862090
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Anticipated Duration (Days): 26
• Patients Per Site Per Month: 46.8

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: RLD2301; Drug: RLD2007	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Apr 5, 2023
• Anticipated Primary Completion Date: May 1, 2023
• Anticipated Study Completion Date: May 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1 Period1 : RLD2301 Period2 : RLD2301 + RLD2007	Drug: RLD2301; Take it once a day per period.; Drug: RLD2007; Take it once a day per period.
Experimental: Arm 2 Period1 : RLD2007 Period2 : RLD2301 + RLD2007	Drug: RLD2301; Take it once a day per period.; Drug: RLD2007; Take it once a day per period.

Outcome Measures

Primary Outcome Measures

1. AUCtau [0~24 hours after final dose administration]

   Pharmacokinetic evaluation

2. Css,max [0~24 hours after final dose administration]

   Pharmacokinetic evaluation

Secondary Outcome Measures

1. Css,min [0~24 hours after final dose administration]

   Pharmacokinetic evaluation

2. Css,av [0~24 hours after final dose administration]

   Pharmacokinetic evaluation

3. Tss,max [0~24 hours after final dose administration]

   Pharmacokinetic evaluation

4. t1/2 [0~24 hours after final dose administration]

   Pharmacokinetic evaluation

5. CLss/F [0~24 hours after final dose administration]

   Pharmacokinetic evaluation

6. Vdss/F [0~24 hours after final dose administration]

   Pharmacokinetic evaluation

7. Fluctuation[(Css,max-Css,min)/Css,av] [0~24 hours after final dose administration]

   Pharmacokinetic evaluation

8. Swing[(Css,max-Css,min)/Css,min] [0~24 hours after final dose administration]

   Pharmacokinetic evaluation

Other Outcome Measures

1. Change of Blood Pressure(SBP/DBP) from baseline [Predose at Day1 and 0~24 hours after final dose administration of each period]

   Pharmacodynamic evaluation

2. Change of pulse rate from baseline [Predose at Day1 and 0~24 hours after final dose administration of each period]

   Pharmacodynamic evaluation

3. Change of blood glucose from baseline [Predose at Day1 and 0~24 hours after final dose administration of each period]

   Pharmacodynamic evaluation

4. AUECtau of Blood Pressure(SBP/DBP) [Predose at Day1 and 0~24 hours after final dose administration of each period]

   Pharmacodynamic evaluation

5. AUECtau of pulse rate [Predose at Day1 and 0~24 hours after final dose administration of each period]

   Pharmacodynamic evaluation

6. AUECtau of blood glucose [Predose at Day1 and 0~24 hours after final dose administration of each period]

   Pharmacodynamic evaluation

7. Emax of Blood Pressure(SBP/DBP) [Predose at Day1 and 0~24 hours after final dose administration of each period]

   Pharmacodynamic evaluation

8. Emax of pulse rate [Predose at Day1 and 0~24 hours after final dose administration of each period]

   Pharmacodynamic evaluation

9. Emax of blood glucose [Predose at Day1 and 0~24 hours after final dose administration of each period]

   Pharmacodynamic evaluation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 54 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jeonbuk University Hospital	Jeonju	Jeollabuk-do	Korea, Republic of

Sponsors and Collaborators

• Hanmi Pharmaceutical Company Limited

Investigators

• Principal Investigator: Min-gul Kim, MD, Jeonbuk National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hanmi Pharmaceutical Company Limited
• ClinicalTrials.gov Identifier: NCT05862090
• Other Study ID Numbers: HM-ENSEMBLE-101
• First Posted: May 17, 2023
• Last Update Posted: May 17, 2023
• Last Verified: May 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of May 17, 2023