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

Healthy Volunteer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04975711
• Other study ID #: HM-ESOB-102
• Status: Completed
• Phase: Phase 1
• Start date: July 12, 2021
• Est. completion date: November 3, 2021

Study information

• Verified date: October 2023
• Source: Hanmi Pharmaceutical Company Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: November 3, 2021
• Est. primary completion date: November 3, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 50 Years

Eligibility

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).

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• HIP2105
Test drug
• RLD2104
Reference drug

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Hanmi Pharmaceutical Company Limited

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUCtau		0-24hours
Primary	changed rate from baseline in 24h integrated gastric pH		0-24hours
Secondary	Cmax		0-24hours
Secondary	Tmax		0-24hours
Secondary	t1/2		0-24hours
Secondary	CL/F		0-24hours
Secondary	Vd/F		0-24hours
Secondary	AUClast		0-24hours
Secondary	Cmin,ss		0-24hours
Secondary	Cmax,ss		0-24hours
Secondary	t1/2,ss		0-24hours
Secondary	CLss/F		0-24hours
Secondary	Vd,ss/F		0-24hours
Secondary	changed rate from baseline in 24h integrated gastric pH		0-24hours
Secondary	Duration time with integrated gastric pH>4 / 24hr		0-24hours
Secondary	Median 24 hr gastric pH		0-24hours