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

NCT02125227 | Completed Phase 1

• 1 other identifier: YH14755-102
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• AUClast of rosuvastatin and metformin

  0~48hr, totally 17 points

• Cmax of rosuvastatin and metformin

  0~48hr, totally 17 points

Secondary Outcomes (4)

• 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

Study Arms (4)

Group 1 of Study A

EXPERIMENTAL

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

Drug: Rosuvastatin, Metformin, YH14755

Group 2 of Study A

EXPERIMENTAL

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

Drug: Rosuvastatin, Metformin, YH14755

Group 1 of Study B

EXPERIMENTAL

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

Drug: YH14755

Group 2 of Study B

EXPERIMENTAL

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

Drug: YH14755

Interventions

Rosuvastatin, Metformin, YH14755 DRUG

single dose

Also known as: Crestor, GlucodaunOR, YH14755

Group 1 of Study A; Group 2 of Study A

YH14755 DRUG

single dose

Group 1 of Study B; Group 2 of Study B

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• History of and clinically significant disease
• A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs.
• Administration of other investigational products within 3 months prior to the first dosing.
• 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).
• Volunteers considered not eligible for the clinical trial by the investigator (study doctor) due to reasons including laboratory test results, ECGs, or vital signs.

Sponsors & Collaborators

• Yuhan Corporation: lead

Study Sites (1)

Chonbuk National University Hospital

Jeonju, Jeollabuk-do, 561712, South Korea

Location

MeSH Terms

Interventions

Rosuvastatin Calcium; Metformin

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Biguanides; Guanidines; Amidines

Study Officials

• Mingul Kim, MD, Ph.D

  Chonbuk National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2014
• First Posted: April 29, 2014
• Study Start: April 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: October 9, 2014

Record last verified: 2014-10

Locations

KR (1)