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NCT02753803 Clinical Trial

Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of Evogliptin 5 mg and Pioglitazone 30 mg

Type 2 Diabetes Clinical Trial

Official title:
A Randomized, Open-label, Multiple Dosing, Three-way Crossover Clinical Trial to Investigate the Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of Evogliptin 5 mg and Pioglitazone 30 mg

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02753803
Other study ID # DA1229_DIP_I
Secondary ID
Status Completed
Phase Phase 1
First received April 25, 2016
Last updated September 15, 2017
Start date July 27, 2016
Est. completion date March 10, 2017

Study information
Verified date September 2017
Source Dong-A ST Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A randomized, open-label, multiple dosing, three-way crossover clinical trial to investigate the pharmacokinetic/pharmacodynamic drug-drug interaction of evogliptin 5 mg and pioglitazone 30 mg after oral administration in healthy male subjects

Description:

A randomized, open-label, multiple-dose, three-treatment, three-period, six-sequence, crossover study

Recruitment information / eligibility
Status Completed
Enrollment 36
Est. completion date March 10, 2017
Est. primary completion date October 19, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 19 Years to 45 Years
Eligibility Inclusion Criteria:

- Healthy Male Volunteers (Age: 19~45years)

- 55<Body Weight<90, 18<BMI<27

- FPG: 70-125 mg/dL

Exclusion Criteria:

- galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption

- Clinically significant Medical History

- Allergy or Drug Hypersensitivity

- AST(SGOT), ALT(SGPT) > Upper Normal Range*1.5, eGFR<80 mL/min

- Drink during clinical trial period

- Smoking during clinical trial period

- Grapefruit/Caffeine intake during clinical trial period

- No Contraception

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Evogliptin, Pioglitazone, Evogliptin+Pioglitazone
Evogliptin : Evogliptin 5mg QD Pioglitazone : Pioglitazone 30mg QD Evogliptin+Pioglitazone : Evogliptin 5mg QD + Pioglitazone 30mg QD
• Pioglitazone, Evogliptin, Evogliptin+Pioglitazone
Pioglitazone : Pioglitazone 30mg QD Evogliptin : Evogliptin 5mg QD Evogliptin+Pioglitazone : Evogliptin 5mg QD + Pioglitazone 30mg QD
• Evogliptin, Evogliptin+Pioglitazone, Pioglitazone
Evogliptin : Evogliptin 5mg QD Evogliptin+Pioglitazone : Evogliptin 5mg QD + Pioglitazone 30mg QD Pioglitazone : Pioglitazone 30mg QD
• Pioglitazone, Evogliptin+Pioglitazone, Evogliptin
Pioglitazone : Pioglitazone 30mg QD Evogliptin+Pioglitazone : Evogliptin 5mg QD + Pioglitazone 30mg QD Evogliptin : Evogliptin 5mg QD
• Evogliptin+Pioglitazone, Evogliptin, Pioglitazone
Evogliptin+Pioglitazone : Evogliptin 5mg QD + Pioglitazone 30mg QD Evogliptin : Evogliptin 5mg QD Pioglitazone : Pioglitazone 30mg QD
• Evogliptin+Pioglitazone, Pioglitazone, Evogliptin
Evogliptin+Pioglitazone : Evogliptin 5mg QD + Pioglitazone 30mg QD Pioglitazone : Pioglitazone 30mg QD Evogliptin : Evogliptin 5mg QD

Locations
Country Name City State
Korea, Republic of Clinical Trials Center, Seoul National University Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Dong-A ST Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary AUC area under the concentration-time curve 1d~6d pre-dose, 15d~20d pre-dose, 29~34d pre-dose, 7d/21d/35d pre-dose and post-dose
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