A Clinical Trial to Compare the Safety, Tolerability, and PK Properties of DA-5216 and DA-5216-R and to Evaluate the Food Effect on DA-5216.

Dong-A ST

Status and phase: Enrolling; Phase 1

Conditions: Healthy

Treatments: Drug: DA-5216-R; Drug: DA-5216

Study type: Interventional

Funder types: Industry

Identifiers

NCT05506007

DA5216_BE_I

Details and patient eligibility

About

This is a randomized, open-label, single dose, 2-part, cross-over clinical trial to compare the safety, tolerability, and pharmacokinetic properties of DA-5216 and DA-5216-R and to evaluate the food effect on DA-5216 in healthy adult subjects

Enrollment: 88 estimated patients

Sex: All

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male and female volunteer 19 years to 50 years
• Body weight in the range of 50.0kg and body mass index in the range of 18 to 27kg/m2
• Subject who are negative in pregnancy test or pregnant or Lactating women
• The subjects personally signed and dated informed consent document after informed of all patient aspects of the study, fully understanding and determined spontaneously to participate
• The subjects who are judged appropriate to participate this clinical trial according to the physical examination, routine laboratory examination and questionnaire

Exclusion criteria

• Subject with serious active hepatobiliary, respiratory, digestive, hematologic, endocrine(diabetes mellitus, aldosteronism), immunologic, cardiovascular(hypertension, angina, heart failure, myocardial infarction, etc.), neurologic, urologic, otorhinolaryngologic, musculoskeletal, psychological disease or history of such disease

• Subject with gastrointestinal disease (Crohn's disease, peptic ulcer, acute or chronic pancreatitis, etc.) or history of such disease/surgery (excluding simple appendic surgery, hernia surgery, hemorrhoid surgery).

• Subject who have galactose intolerance, Lapp lactase deficiency or glucose galactose malabsorption

• Subject who have had one or more of the following findings

  • AST, ALT > 1.5 times the upper limit
  • CPK > 2.5 times the upper limit
  • eGFR <60mL/min/1.73m2

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

88 participants in 4 patient groups

[Part A] DA-5216

Experimental group

Treatment:

Drug: DA-5216

Drug: DA-5216

Drug: DA-5216

[Part A] DA-5216-R

Experimental group

Treatment:

Drug: DA-5216-R

[Part B] DA-5216(Fasting)

Experimental group

Treatment:

Drug: DA-5216

Drug: DA-5216

Drug: DA-5216

[Part B] DA-5216(Fed)

Experimental group

Treatment:

Drug: DA-5216

Drug: DA-5216

Drug: DA-5216