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

Hanmi Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: RLD2104; Drug: HIP2105

Study type: Interventional

Funder types: Industry

Identifiers

NCT04975711

HM-ESOB-102

Details and patient eligibility

About

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

Full description

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

Enrollment: 48 patients

Sex: All

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

Test drug(HIP2105) or Reference drug(RLD2104) Sequence 1

Experimental group

Description:

Period 1: RLD2104 Period 2: HIP2105

Treatment:

Drug: RLD2104

Drug: HIP2105

Test drug(HIP2105) or Reference drug(RLD2104) Sequence 2

Experimental group

Description:

Period 1: HIP2105 Period 2: RLD2104

Treatment:

Drug: RLD2104

Drug: HIP2105