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Completed

NCT Number: NCT04975711

Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of HIP2105 to RLD2104 in Healthy Volunteers

A Phase 1 Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of HIP2105 to RLD2104 in Healthy Volunteers

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Key information

Conditions

Age range

19 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Hospital

Seoul, South Korea

About this study

A Randomized, Open-label, Multiple dose, Crossover Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of HIP2105 to RLD2104 in Healthy Volunteers

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy volunteers in the age between 19 and 50 years old.
  • Body mass index (BMI) in the range of 19 to 28 kg/m2 and weight 55.0kg to 90.0kg.
  • After fully hearing and understanding the details of this clinical trial, Subjects who have willingness to sign of informed consent before the screening.
  • Subject who are eligible from physical examination, clinical laboratory test by investigators judgment.

Exclusion criteria

  • Gastrointestinal disorders (gastrointestinal ulcers, gastritis, stomach cramps, gastro-esophageal reflux disease, Crohn's disease or chronic pancreatitis) or gastrointestinal surgery (except for simple cecal or hernia surgery) which may affect the safety and pharmacokinetic evaluation of test drug.
  • Subjects who have a history of hypersensitivity or clinically significant hypersensitivity to investigational product or the same component or other drugs (aspirin, antibiotics, etc.).
  • Aspartate aminotransferase and alanine aminotransferase exceed 1.5 times the upper limit of normal range from screening laboratory results before randomization.
  • Subject who continues to drink (21 units / week, 1 unit = 10 g of pure alcohol) within a month before the screening visit or who cannot abstain during the hospital stay.
  • Heavy smoker (>10 cigarettes/day).

Treatment and study plan

HIP2105

Drug

Test drug

RLD2104

Drug

Reference drug

Primary outcomes

  1. AUCtau

    Time frame: 0-24hours

  2. changed rate from baseline in 24h integrated gastric pH

    Time frame: 0-24hours

Secondary outcomes

  1. Cmax

    Time frame: 0-24hours

  2. Tmax

    Time frame: 0-24hours

  3. t1/2

    Time frame: 0-24hours

  4. CL/F

    Time frame: 0-24hours

  5. Vd/F

    Time frame: 0-24hours

  6. AUClast

    Time frame: 0-24hours

  7. Cmin,ss

    Time frame: 0-24hours

  8. Cmax,ss

    Time frame: 0-24hours

  9. t1/2,ss

    Time frame: 0-24hours

  10. CLss/F

    Time frame: 0-24hours

  11. Vd,ss/F

    Time frame: 0-24hours

  12. changed rate from baseline in 24h integrated gastric pH

    Time frame: 0-24hours

  13. Duration time with integrated gastric pH>4 / 24hr

    Time frame: 0-24hours

  14. Median 24 hr gastric pH

    Time frame: 0-24hours

Sponsors and collaborators

Lead sponsor

Hanmi Pharmaceutical Company Limited

Industry

Registry information

Official study title

A Randomized, Open-label, Multiple Dose, Crossover Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of HIP2105 to RLD2104 in Healthy Volunteers

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jul 23, 2021
Registry last updated
Oct 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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