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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02125227

Enrollment

Registered

2014-04-29

Start date

2014-04-30

Completion date

2014-09-30

Last updated

2014-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

DRUGRosuvastatin, Metformin, YH14755

single dose

DRUGYH14755

single dose

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Secondary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026