Drug-drug Interaction Study(Lobeglitazone, Warfarin)

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Open Label, Randomized, Crossover Study to Evaluate a Pharmacokinetic Drug Interaction Between Lobeglitazone and Warfarin in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02002611
• Other study ID #: 19DDI13016
• Status: Completed
• Phase: Phase 1
• First received: November 25, 2013
• Last updated: July 1, 2014
• Start date: December 2013
• Est. completion date: May 2014

Study information

• Verified date: July 2014
• Source: Chong Kun Dang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate a pharmacokinetic drug interaction between lobeglitazone and warfarin in healthy subjects.

Description:

From day 1 to day 12, lobeglitazone 0.5mg is administered daily to Group 1 subjects during period 1. Then on day 5,warfarin 25mg is co-administered Group 1 subjects at period 1. After 10 day-break, warfarin 25mg is administered Group 1 subjects at period 2. On period 2, lobeglitazone is not administered.

Group 2 is administered in reverse order.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 55 Years

Eligibility

Inclusion Criteria:

• A healthy male volunteer between 19 and 55 years old.

• BMI between 19 and 27.

• Signed the informed consent form prior to study participation.

• Able to participate in the entire trial

Exclusion Criteria:

• Clinically significant hepatic, renal, digestive system, respiratory system, endocrine system, nervous system, hematologic, cardiovascular system, tumor or have history of tumor

• Clinically significant hemorrhagic disease

• Genetic problems such as galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption

• Have hypersensitivity reactions history for lobeglitazone, warfarin, excipient of IP or aspirin, antibiotics

• Medication which might significantly alter the absorption, distribution, metabolism, or excretion of investigational products within 30 days prior to screening

• Participated in the other clinical trials and administrated IP within 60 days prior to screening

• Subject takes ethical drug or herbal medicine within 14 days, OTC within 7 days before screening

• Previously donate whole blood within 60 days or component blood within 30 days

• sit SBP < 90mmHg or sit SBP = 140mmHg or sit DBP < 60mmHg or sit DBP = 90mmHg

• A heavy alcohol consumer (alcohol > 140 g/week) or cannot stop drinking

• A heavy smoker (cigarette > 10 cigarettes per day) or cannot stop smoking

• A heavy caffeine consumer (more than 4cups per a day) or A heavy grapefruit consumer (more than 1cup per a day) or cannot stop having

• Positive for the Triage TOX drug on urine

• Positive for HIV antibody, HBsAg, HCV antibody test

• AST, ALT or Total bilirubin > UNL * 1.5

• Estimated GFR < normal limit

• INR, aPTT over the normal limit

• Clinically significant laboratory test result

• Clinically significant ECG

• An impossible one who participates in clinical trial by investigator's decision including other reason

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Lobeglitazone

• Warfarin

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess AUC of lobeglitazone		0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24h	No
Primary	Assess Cmax of lobeglitazone		0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24h	No
Primary	Assess AUC of S-warfarin		0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168h	No
Primary	Assess Cmax of S-warfarin		0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168h	No
Primary	Assess AUC of R-warfarin		0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168h	No
Primary	Assess Cmax of R-warfarin		0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168h	No
Secondary	Assess tmax of lobeglitazone		0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24h	No
Secondary	Assess t1/2 of lobeglitazone		0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24h	No
Secondary	Assess CL/F of lobeglitazone		0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24h	No
Secondary	Assess Vd/F of lobeglitazone		0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24h	No
Secondary	Assess tmax of S-warfarin		0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168h	No
Secondary	Assess t1/2 of S-warfarin		0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168h	No
Secondary	Assess CL/F of S-warfarin		0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168h	No
Secondary	Assess Vd/F of S-warfarin		0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168h	No
Secondary	Assess tmax of R-warfarin		0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168h	No
Secondary	Assess t1/2 of R-warfarin		0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168h	No
Secondary	Assess CL/F of R-warfarin		0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168h	No
Secondary	Assess Vd/F of R-warfarin		0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168h	No