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Clinical trial

A Bioequivalence Study to Compare and Evaluate the Pharmacokinetic Characteristics and the Safety After Administration of DW5221 and DW5221-R in Healthy Adult Male Volunteers

ID
Name
DW5221-1
Description
A bioequivalence study to compare and evaluate the pharmacokinetic characteristics and the safety after administration of DW5221 and DW5221-R in healthy adult m ale volunteers
Trial arms
Trial start
2022-07-01
Estimated PCD
2022-10-26
Trial end
2022-11-17
Status
Completed
Phase
Early phase I
Treatment
DW5221
megestrol acetate
Arms:
Sequence A, Sequence B
Other names:
Test
DW5221-R
megestrol acetate
Arms:
Sequence A, Sequence B
Other names:
Reference
Size
54
Primary endpoint
Peak Plasma Concentration (Cmax)
up to 120 hour
Area under the plasma concentration versus time curve (AUC)
up to 120 hour
Eligibility criteria
Inclusion Criteria: * Healthy Male Volunteers who are ≥19 years old * Body weight ≥50.0 kg and BMI between 18.0 and 30.0 kg/m2 and Exclusion Criteria: * Clinically significant Medical History
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 54, 'type': 'ACTUAL'}}
Updated at
2023-11-28

1 organization

2 products

1 indication

Organization
Daewon Pharmaceutical
Product
DW5221-R
Indication
Appetite Stimulants
Product
DW5221