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

A Randomized, Open-label, Single-dose, 2-Way Cross-over Study 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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Rosuvastatin, Metformin, YH14755; Drug: YH14755

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jeollabuk-do
    • Jeonju-si, Jeollabuk-do, Korea, Republic of, 561712
      • Chonbuk National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1 of Study A; single dosing of Rosuvastatin and Metformin 14 days later, single dosing of YH14755	Drug: Rosuvastatin, Metformin, YH14755; single dose; Other Names: Crestor, GlucodaunOR, YH14755
Experimental: Group 2 of Study A; single dosing of YH14755 14 days later, single dosing of Rosuvastatin and Metformin	Drug: Rosuvastatin, Metformin, YH14755; single dose; Other Names: Crestor, GlucodaunOR, YH14755
Experimental: Group 1 of Study B; single dosing of YH14755 with fasting state 14 days later, single dosing of YH14755 after having breakfast	Drug: YH14755; single dose
Experimental: Group 2 of Study B; single dosing of YH14755 after having breakfast 14 days later, single dosing of YH14755 with fasting state	Drug: YH14755; single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
AUClast of rosuvastatin and metformin	0~48hr, totally 17 points
Cmax of rosuvastatin and metformin	0~48hr, totally 17 points

Secondary Outcome Measures

Outcome Measure	Time Frame
Tmax of rosuvastatin and metformin	0~48hr, totally 17 points
t1/2 of rosuvastatin and metformin	0~48hr, totally 17 points
%AUC of rosuvastatin and metformin	0~48hr, totally 17 points
AUCinf of rosuvastatin and metformin	0~48hr, totally 17 points

Collaborators and Investigators

• Sponsor: Yuhan Corporation
• Investigators: Principal Investigator: Mingul Kim, MD, Ph.D, Chonbuk National University Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: April 24, 2014
• First Submitted That Met QC Criteria: April 28, 2014
• First Posted (Estimate): April 29, 2014

Study Record Updates

• Last Update Posted (Estimate): October 9, 2014
• Last Update Submitted That Met QC Criteria: October 8, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Rosuvastatin Calcium; Metformin
• Other Study ID Numbers: YH14755-102