A Study to Evaluate the Pharmacokinetics and Safety Between HCP2303 and Co-administration of Each Component in Healthy Volunteers Under Fed Conditions

NCT06357910 | Completed Phase 1

• 1 other identifier: HM-EMMA-102
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the pharmacokinetic characteristics and safety between HCP2303 and co-administration of each component in fed condition in healthy volunteers.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• AUCt

  Pharmacokinetic evaluation

  0~48 hours

• Cmax

  Pharmacokinetic evaluation

  0~48 hours

Secondary Outcomes (5)

• AUCinf

  0~48 hours

• Tmax

  0~48 hours

• t1/2

  0~48 hours

• CL/F

  0~48 hours

• Vd/F

  0~48 hours

Study Arms (2)

Arm 1

EXPERIMENTAL

* Period1 : RLD2302 + RLD2102 * Period2 : HCP2303

Drug: HCP2303; Drug: RLD2302; Drug: RLD2102

Arm 2

EXPERIMENTAL

* Period1 : HCP2303 * Period2 : RLD2302 + RLD2102

Drug: HCP2303; Drug: RLD2302; Drug: RLD2102

Interventions

HCP2303 DRUG

Take 1 tablet once per period

Arm 1; Arm 2

RLD2302 DRUG

Take 1 tablet once per period

Arm 1; Arm 2

RLD2102 DRUG

Take 1 tablet once per period

Arm 1; Arm 2

Eligibility Criteria

• Age: 19 Years - 54 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 19\~54 years in healthy volunteers
• kg/m\^2 ≤ BMI \< 30 kg/m\^2, weight(men) ≥55kg / weight(women) ≥45kg
• mmHg ≤ sitSBP \<140 mmHg, 50 mmHg ≤ sitDBP \<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

You may not qualify if:

• 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 cannot consume the high-fat meal provided during this clinical trial
• Subjects who judged ineligible by the investigator

Sponsors & Collaborators

• Hanmi Pharmaceutical Company Limited: lead

Study Sites (1)

Jeonbuk University Hospital

Jeonju, Jeollabuk-do, South Korea

Location

Study Officials

• Min-gul Kim, MD

  Jeonbuk National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2024
• First Posted: April 10, 2024
• Study Start: May 17, 2024
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: July 16, 2024

Record last verified: 2024-07

Locations

KR (1)