A Study to Evaluate Pharmacokinetic/Pharmacodynamic Drug-drug Interaction and Safety/Tolerability Between RLD2202 and RLD2203

• Sponsor: Hanmi Pharmaceutical Company Limited (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05481307
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 2.5
• Patients Per Site Per Month: 9.7

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate pharmacokinetic/pharmacodynamic drug-drug interactions and safety/tolerability between RLD2202 and RLD2203 in healthy adult subjects

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: RLD2202; Drug: RLD2203	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 24 participants
• Allocation: N/A
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-label Phase 1 Study to Evaluate PK/PD Drug-drug Interactions and Safety/Tolerability Between RLD2202 and RLD2203 in Healthy Adult Subjects
• Anticipated Study Start Date: Aug 2, 2022
• Anticipated Primary Completion Date: Oct 16, 2022
• Anticipated Study Completion Date: Oct 16, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Fixed Sequence Period 1: RLD2202, Period 2 : RLD2203 -> RLD2202+RLD2203	Drug: RLD2202; Take it once a day per period; Drug: RLD2203; Take it once a day per period

Outcome Measures

Primary Outcome Measures

1. Cmax,ss of RLD2202 [0~24 hours]

   Pharmacokinetic evaluation

2. AUCtau,ss of RLD2202 [0~24 hours]

   Pharmacokinetic evaluation

3. Cmax,ss of RLD2203 [0~24 hours]

   Pharmacokinetic evaluation

4. AUCtau,ss of RLD2203 [0~24 hours]

   Pharmacokinetic evaluation

5. Inhibition of Platelet Aggregation(%) [0~6 days]

   Pharmacodynamic evaluation

6. Inhibition of Thromboxane B2(%) [0~6 days]

   Pharmacodynamic evaluation

Secondary Outcome Measures

1. Tmax,ss of RLD2202 and RLD2203 [0~24 hours]

   Pharmacokinetic evaluation

2. t1/2,ss of RLD2202 and RLD2203 [0~24 hours]

   Pharmacokinetic evaluation

3. Cmin,ss of RLD2202 and RLD2203 [0~24 hours]

   Pharmacokinetic evaluation

4. Cavg,ss of RLD2202 and RLD2203 [0~24 hours]

   Pharmacokinetic evaluation

5. CLss/F of RLD2202 and RLD2203 [0~24 hours]

   Pharmacokinetic evaluation

6. Vdss/F of RLD2202 and RLD2203 [0~24 hours]

   Pharmacokinetic evaluation

7. PTF of RLD2202 and RLD2203 [0~24 hours]

   Pharmacokinetic evaluation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

• Inclusion Criteria:

1. Healthy adults in the age between 19 and 50 years old

2. Body mass index (BMI) in the range of 18 to 27 kg/m2 and weight 50kg to 90kg.

3. After fully hearing and understanding the details of this clinical trial, Subjects who have willingness to sign of informed consent before the screening.

4. Subject who are eligible from physical examination, clinical laboratory test by investigators judgment.

• Exclusion Criteria:

1. 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

2. Subjects who judged ineligible by the investigator

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• Hanmi Pharmaceutical Company Limited

Investigators

• Principal Investigator: SeungHwan Lee, M.D., Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hanmi Pharmaceutical Company Limited
• ClinicalTrials.gov Identifier: NCT05481307
• Other Study ID Numbers: HM-SARA-101
• First Posted: Aug 1, 2022
• Last Update Posted: Aug 2, 2022
• Last Verified: Jul 1, 2022

• 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 Aug 2, 2022