Phase 1 Clinical Trial to Investigate the Effect on the Pharmacokinetics of YH14755 Compared to Co-administration of Rosuvastatin and Metformin SR in Healthy Volunteers

Yuhan

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: YH14755; Drug: Rosuvastatin, Metformin, YH14755

Study type: Interventional

Funder types: Industry

Identifiers

NCT02125227

YH14755-102

Details and patient eligibility

About

The objective of this study is to Compare the Safety and the Pharmacokinetic Characteristics of the Co-administration of Rosuvastatin and Metformin SR and YH14755 and to Investigate the Effect of Food on the Pharmacokinetics of YH14755 in healthy volunteers.

Enrollment: 56 patients

Sex: All

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy male and female with a body mass index(BMI) between 18.5 and 25 kg/m2
2. Who has not suffered from clinically significant disease
3. Provision of signed written informed consent

Exclusion criteria

1. History of and clinically significant disease
2. A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs.
3. Administration of other investigational products within 3 months prior to the first dosing.
4. Administration of herbal medicine within 4 weeks or administration of ethical drugs within 2 weeks or administration of over-the-counter (OTC) drugs within 1 week prior to the first dosing of the investigational product (if the investigator (study doctor) determines that the person meets other criteria appropriately, the relevant person may participate in the study).
5. Volunteers considered not eligible for the clinical trial by the investigator (study doctor) due to reasons including laboratory test results, ECGs, or vital signs.

Trial design

56 participants in 4 patient groups

Group 1 of Study A

Experimental group

Description:

single dosing of Rosuvastatin and Metformin 14 days later, single dosing of YH14755

Treatment:

Drug: Rosuvastatin, Metformin, YH14755

Group 2 of Study A

Experimental group

Description:

single dosing of YH14755 14 days later, single dosing of Rosuvastatin and Metformin

Treatment:

Drug: Rosuvastatin, Metformin, YH14755

Group 1 of Study B

Experimental group

Description:

single dosing of YH14755 with fasting state 14 days later, single dosing of YH14755 after having breakfast

Treatment:

Drug: YH14755

Group 2 of Study B

Experimental group

Description:

single dosing of YH14755 after having breakfast 14 days later, single dosing of YH14755 with fasting state

Treatment:

Drug: YH14755