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Not yet recruiting NCT07297693

A Study to Evaluate the Pharmacokinetics and Safety Between HIP2503 and HCP1306 in Healthy Volunteers

Phase I Interventional Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HIP2503, HCP1306.
Who it may be relevant to
Registry conditions: Healthy. Basic parameters: 19 years — 64 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

An Open-label, Randomized, Single-dose, Oral Administration, 2-sequence, 2-period, Crossover Study to Evaluate the Pharmacokinetics and Safety Between HIP2503 and HCP1306 in Healthy Subjects

Overview

The purpose of this study is to evaluate the pharmacokinetic characteristics and safety between HIP2503 and HCP1306 in healthy volunteers.

Interventions

  • Drug HIP2503
    Take 1 orally disintegrating tablet once per period
  • Drug HCP1306
    Take 1 tablet once per period

Primary outcome measures

  • AUCt [Time frame: 0~72 hours]
  • Cmax [Time frame: 0~72 hours]
Secondary outcome measures (6)
  • Ka [Time frame: 0~72 hours]
  • Concentration/Cmax_% [Time frame: 0~72 hours]
  • AUCinf [Time frame: 0~72 hours]
  • AUCt/AUCinf [Time frame: 0~72 hours]
  • Tmax [Time frame: 0~72 hours]
  • t1/2 [Time frame: 0~72 hours]

Eligibility criteria

Inclusion criteria

  • Age 19\~64 years in healthy volunteers
  • 18 kg/m\^2 ≤ BMI ≤ 30 kg/m\^2, weight(men) ≥55kg / weight(women) ≥45kg
  • 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 14 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
  • Subjects who judged ineligible by the investigator

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Treatment

Study locations

South Korea · 1 center
  • H plus Yangji Hospital — Seoul

Identifiers

NCT: NCT07297693 · HM-RIZE-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗