- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04946903
A Study to Evaluate the Pharmacokinetics and Safety Between HCP1902 and Co-administration of RLD2007, RLD2008
July 31, 2022 updated by: Hanmi Pharmaceutical Company Limited
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
The purpose of this study is to evaluate the pharmacokinetic characteristics and safety between HCP1902 and co-administration of RLD2007/RLD2008 in healthy volunteers
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
33
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Jeollabuk-do
-
Jeonju, Jeollabuk-do, Korea, Republic of
- Chonbuk National University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 54 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sequence 1
Period 1: Fasted state + RLD2007 +RLD2008, Period 2: Fasted state + HCP1902 |
Take it once per period.
Take it once per period.
Take it once per period.
|
Experimental: Sequence 2
Period 1: Fasted state + HCP1902, Period 2: Fasted state + RLD2007 + RLD2008 |
Take it once per period.
Take it once per period.
Take it once per period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
AUCt
Time Frame: 0~48 hour
|
Pharmacokinetic evaluation
|
0~48 hour
|
Cmax
Time Frame: 0~48 hour
|
Pharmacokinetic evaluation
|
0~48 hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
AUCinf
Time Frame: 0~48 hour
|
Pharmacokinetic evaluation
|
0~48 hour
|
Tmax
Time Frame: 0~48 hour
|
Pharmacokinetic evaluation
|
0~48 hour
|
t1/2
Time Frame: 0~48 hour
|
Pharmacokinetic evaluation
|
0~48 hour
|
CL/F
Time Frame: 0~48 hour
|
Pharmacokinetic evaluation
|
0~48 hour
|
Vd/F
Time Frame: 0~48 hour
|
Pharmacokinetic evaluation
|
0~48 hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Mingeul Kim, Jeonbuk University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 10, 2021
Primary Completion (Actual)
August 10, 2021
Study Completion (Actual)
August 10, 2021
Study Registration Dates
First Submitted
June 23, 2021
First Submitted That Met QC Criteria
June 23, 2021
First Posted (Actual)
July 1, 2021
Study Record Updates
Last Update Posted (Actual)
August 2, 2022
Last Update Submitted That Met QC Criteria
July 31, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- HM-DATA-101
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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