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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Rosuvastatin, Metformin, YH14755; Drug: YH14755

• Registration Number: NCT02125227
• Lead Sponsor: Yuhan Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-04-24
• Study First Submitted QC: 2014-04-28
• Study First Posted: 2014-04-29
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-08
• Last Update Posted: 2014-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 2 of Study A	Rosuvastatin, Metformin, YH14755	single dosing of YH14755 14 days later, single dosing of Rosuvastatin and Metformin
Group 1 of Study A	Rosuvastatin, Metformin, YH14755	single dosing of Rosuvastatin and Metformin 14 days later, single dosing of YH14755
Group 1 of Study B	YH14755	single dosing of YH14755 with fasting state 14 days later, single dosing of YH14755 after having breakfast
Group 2 of Study B	YH14755	single dosing of YH14755 after having breakfast 14 days later, single dosing of YH14755 with fasting state

Primary Outcome Measures

Name	Time	Method
Cmax of rosuvastatin and metformin	0~48hr, totally 17 points
AUClast of rosuvastatin and metformin	0~48hr, totally 17 points

Secondary Outcome Measures

Name	Time	Method
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
Tmax of rosuvastatin and metformin	0~48hr, totally 17 points

Trial Locations

Locations (1)

Chonbuk National University Hospital; 🇰🇷 Jeonju-si, Jeollabuk-do, Korea, Republic of