Status:
COMPLETED
Bioequivalence Study Between YHP1906 Tab. 5 mg and YHR1902 Tab. 5 mg
Lead Sponsor:
Yuhan Corporation
Collaborating Sponsors:
Metro Hospital
Conditions:
Healthy Volunteers
Eligibility:
All Genders
19+ years
Phase:
PHASE1
Brief Summary
A randomized, open-label, single-dose, 2-sequence, 2-period, crossover clinical trial to investigate the bioequivalence between YHP1906 Tab. 5 mg and YHR1902 Tab. 5mg in healthy volunteers
Detailed Description
30 healthy subjects will be randomized to one of the 2 groups in the same ratio. Subjects in group 1 will be administered "comparator" and "YHP1906 Tab. 5 mg" by cross-over design on day 1, 8. Subje...
Eligibility Criteria
Inclusion
- Healthy adults aged 19 and above with body mass index(BMI) between 18.5 and 30.0 kg/m2
- Acceptable medical history, physical examination and laboratory tests during screening
- Subjects who has signed a written informed consent voluntarily, prior to any procedure, using a form that is approved by the local Institutional Review Board after detailed explanation of the purpose, contents, and characteristic of the drug
Exclusion
- History of clinically significant disease
- Administration of ETC(ethical-the-counter drug) within 2 weeks or OTC(over-the-counter drug) within 1 week prior to the first dosing
- Have AST(GOT) and/or ALT(GPT) and/or GGT(γGT) and/or Total Bilirubin \> 1.5 times of normal upper limit
- Volunteers considered not eligible for the clinical trial by the investigator
- Administration of other investigational products within 6 months prior to the first dosing
Key Trial Info
Start Date :
April 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 24 2020
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04316065
Start Date
April 11 2020
End Date
April 24 2020
Last Update
May 26 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Metro Hospital
Anyang-si, Gyeonggi-do, South Korea, 14096