Bioequivalence Study Between YHP1906 Tab. 5 mg and YHR1902 Tab. 5 mg

Yuhan

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: YHP1906; Drug: YHR1902

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT04316065

YHP1906-101

Details and patient eligibility

About

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

Full 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.

Subjects in group 2 will be administered "YHP1906 Tab. 5 mg" and "comparator" by cross-over design on day 1, 8

Enrollment: 30 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy adults aged 19 and above with body mass index(BMI) between 18.5 and 30.0 kg/m2
2. Acceptable medical history, physical examination and laboratory tests during screening
3. 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 criteria

1. History of clinically significant disease
2. Administration of ETC(ethical-the-counter drug) within 2 weeks or OTC(over-the-counter drug) within 1 week prior to the first dosing
3. Have AST(GOT) and/or ALT(GPT) and/or GGT(γGT) and/or Total Bilirubin > 1.5 times of normal upper limit
4. Volunteers considered not eligible for the clinical trial by the investigator
5. Administration of other investigational products within 6 months prior to the first dosing

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Group 1

Other group

Description:

15 subjects, Cross-over, Single dose of comparator on day 1, Single dose of YHP1906 on day 8

Treatment:

Drug: YHR1902

Drug: YHP1906

Group 2

Other group

Description:

15 subjects, Cross-over, Single dose of YHP1906 on day 1, Single dose of comparator on day 8

Treatment:

Drug: YHR1902

Drug: YHP1906