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

• Status: Completed
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Yuhan Corporation
• Treatments: Metformin; Rosuvastatin Calcium

Criteria

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.