A Study to Evaluate the Pharmacokinetics and Safety Between HCP1902 and Co-administration of RLD2007, RLD2008

• Sponsor: Hanmi Pharmaceutical Company Limited (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04946903
• Collaborator: (none)
• Enrollment: 33
• Location: 1
• Arms: 2
• Actual Duration (Months): 2
• Patients Per Site Per Month: 16.5

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the pharmacokinetic characteristics and safety between HCP1902 and co-administration of RLD2007/RLD2008 in healthy volunteers

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: RLD2007; Drug: RLD2008; Drug: HCP1902	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 33 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized, Open Label, Single Dose, 2-way Crossover Clinical Trial to Evaluate the Pharmacokinetic Characteristics and Safety Between HCP1902 and RLD2007/RLD2008 in Healthy Volunteers
• Actual Study Start Date: Jun 10, 2021
• Actual Primary Completion Date: Aug 10, 2021
• Actual Study Completion Date: Aug 10, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sequence 1 Period 1: Fasted state + RLD2007 +RLD2008, Period 2: Fasted state + HCP1902	Drug: RLD2007; Take it once per period.; Drug: RLD2008; Take it once per period.; Drug: HCP1902; Take it once per period.
Experimental: Sequence 2 Period 1: Fasted state + HCP1902, Period 2: Fasted state + RLD2007 + RLD2008	Drug: RLD2007; Take it once per period.; Drug: RLD2008; Take it once per period.; Drug: HCP1902; Take it once per period.

Outcome Measures

Primary Outcome Measures

1. AUCt [0~48 hour]

   Pharmacokinetic evaluation

2. Cmax [0~48 hour]

   Pharmacokinetic evaluation

Secondary Outcome Measures

1. AUCinf [0~48 hour]

   Pharmacokinetic evaluation

2. Tmax [0~48 hour]

   Pharmacokinetic evaluation

3. t1/2 [0~48 hour]

   Pharmacokinetic evaluation

4. CL/F [0~48 hour]

   Pharmacokinetic evaluation

5. Vd/F [0~48 hour]

   Pharmacokinetic 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 19 kg/m^{2 ≤ BMI < 28 kg/m}2, weight(men) ≥55kg / weight(women) ≥45kg

• 90 mmHg ≤ SBP <140 mmHg, 50 mmHg ≤ DBP <90 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.

• 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	Chonbuk National University Hospital	Jeonju	Jeollabuk-do	Korea, Republic of

Sponsors and Collaborators

• Hanmi Pharmaceutical Company Limited

Investigators

• Principal Investigator: Mingeul Kim, Jeonbuk University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hanmi Pharmaceutical Company Limited
• ClinicalTrials.gov Identifier: NCT04946903
• Other Study ID Numbers: HM-DATA-101
• First Posted: Jul 1, 2021
• 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