Study to Evaluate the Safety and Pharmacodynamic/Pharmacokinetic Characteristics of HIP2101 in Healthy Volunteers

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Hanmi Pharmaceutical

Status and phase

Completed
Phase 1

Conditions

Healthy Adult Volunteer

Treatments

Drug: HIP2101
Drug: RLD2101

Study type

Interventional

Funder types

Industry

Identifiers

NCT04967014
HM-ESOL-101

Details and patient eligibility

About

A Phase 1 Study to Evaluate the Safety and Pharmacodynamic/Pharmacokinetic Characteristics of HIP2101 in Healthy Volunteers

Full description

A Randomized, Open-label, Multiple-dose, Crossover Phase 1 Clinical Trial to Evaluate the Safety and Pharmacodynamic/Pharmacokinetic Characteristics after Oral Administration of HIP2101 in Healthy Adult Volunteers

Enrollment

32 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 18 to 30 kg/m2 and weight 50.0kg 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 (Crohn's disease or Acute/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.
  • Aspartate aminotransferase and alanine aminotransferase exceed 2 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 6 months before the first administration or who cannot abstain from consent to post-study visit.
  • Heavy smoker (>10 cigarettes/day).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

32 participants in 2 patient groups

Sequence A
Experimental group
Description:
Period I : RLD2104 Period II : HIP2104
Treatment:
Drug: RLD2101
Drug: HIP2101
Sequence B
Experimental group
Description:
Period I : HIP2104 Period II : RLD2104
Treatment:
Drug: RLD2101
Drug: HIP2101

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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