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Clinical trial

An Open Label, Randomized, Single Dose, Cross-over ,Two-group Study to Evaluate the Pharmacokinetics and Safety of DA-1229_01 5/1000mg in Healthy Subjects at Fed State

ID
Name
22-4250-BE025
Description
This Phase I clinical study is to evaluate the safety/tolerability and pharmacokinetics of DA-1229_01(5/1000 mg x1 tablets) at fed state.
Trial arms
Trial start
2023-03-30
Estimated PCD
2023-04-28
Trial end
2023-04-28
Status
Not yet recruiting
Phase
Early phase I
Treatment
DA-1229_01 5/1000mg (Before)
single dose administration (one tablet once a day)
Arms:
Sequence A(Before→ After), Sequence B(After→ Before)
DA-1229_01 5/1000mg (After)
single dose administration (one tablet once a day)
Arms:
Sequence A(Before→ After), Sequence B(After→ Before)
Size
34
Primary endpoint
AUCt
pre-dose~48 hours post-dose
Cmax
pre-dose~48 hours post-dose
Eligibility criteria
Inclusive Criteria: * Healthy Volunteers * BMI between 18 and 30 kg/m2 * Body weight : Male≥50kg, Female≥45kg Exclusion Criteria: * Allergy or Drug hypersensitivity * Clinically significant Medical History
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 34, 'type': 'ESTIMATED'}}
Updated at
2023-02-22

1 organization

1 product

1 indication

Product
DA-1229_01
Indication
Healthy
Organization
Dong-A ST