CKD-396 Drug-drug Interaction Study(B) (CKD-396 DDI(B) P1)

NCT02827890 | Completed Phase 1

• 1 other identifier: 165DDI16003
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate a pharmacokinetic drug interaction between sitagliptin and lobeglitazone in healthy male volunteers.

Conditions

Diabetes Mellitus Type 2

Outcome Measures

Primary Outcomes (2)

• AUCτ of Sitagliptin

  1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h

• Css,max of Sitagliptin

  1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h

Secondary Outcomes (8)

• Css,min of Sitagliptin

  1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h

• Css,av of Sitagliptin

  1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h

• Tss,max of Sitagliptin

  1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h

• t1/2 of Sitagliptin

  1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h

• CLss/F of Sitagliptin

  1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h

Study Arms (2)

Group 1(Treatment A/Treatment B)

EXPERIMENTAL

Period 1: Treatment A(Januvia Tab. 100mg)\*1T/day for 5 days, QD, PO. Period 2: Treatment B(Januvia Tab. 100mg + Duvie Tab. 0.5mg)\*1T/day for 5 dyas, QD, PO. Each treatment period was separated by a washout period of at least 10 dyas.

Drug: Januvia Tab. 100mg; Drug: Januvia Tab. 100mg + Duvie Tab. 0.5mg

Group 2(Treatment B/Treatment A)

EXPERIMENTAL

Period 1: Treatment B(Januvia Tab. 100mg + Duvie Tab. 0.5mg)\*1T/day for 5 dyas, QD, PO. Period 2: Treatment A(Januvia Tab. 100mg)\*1T/day for 5 dyas, QD, PO. Each treatment period was separated by a washout period of at least 10 dyas.

Drug: Januvia Tab. 100mg; Drug: Januvia Tab. 100mg + Duvie Tab. 0.5mg

Interventions

Januvia Tab. 100mg DRUG

Januvia Tab. 100mg\*1T/day for 5days, QD, PO

Also known as: Sitagliptin 100mg

Group 1(Treatment A/Treatment B); Group 2(Treatment B/Treatment A)

Januvia Tab. 100mg + Duvie Tab. 0.5mg DRUG

Januvia Tab.100mg + Duvie Tab. 0.5mg\*1T/day for 5 dyas, QD, PO

Also known as: Sitagliptin 100mg, Lobeglitazone 0.5mg

Group 1(Treatment A/Treatment B); Group 2(Treatment B/Treatment A)

Eligibility Criteria

• Age: 19 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A healthy male whose age is over 19 years old when visiting for initial screening test.
• Body mass index(BMI) between 17.5\~30.5 kg/m\^2 and the body weight must be over 55kg (Body mass index (BMI) = weight (kg) / height (m)\^2) .
• A male with no congenital or chronic disease in three years, no history of symptoms in internal treatment, or no knowledge in the area.
• Due to the special characteristics of drugs, the participators must be qualified to do the clinical screening after examined through hematology test and blood chemistry analysis, urinary test, the electrocardiogram (ECG), and etc.
• The participants must be volunteered and sign in an informed consent document proven by Chonbuk National University IRB before joining a study to show that he was given informed the purpose of tests and the special characteristics of drugs.
• The participants must have an ability and willingness to participate throughout the entire trials.

You may not qualify if:

• A person who had a history or symptoms of clinically aware of blood, kidney, internal secretion, gastrointestinal, urinary system, cardiovascular, liver, mental, nercous, or allergic(except subclinical seasonal allergies that is not treated at injecion) desease.
• Who had a gistory of gastrointestinal related disease which can be affected the drug absorption (esophageal achalasia, esophagostenosis, esophageal disease, or Crohn's disease) or surgeries (except a simple appendectomy or herniotomy).
• Who had following results after examination(a. ALT or AST \> twice higher than normal value).
• Who constantly intake 210 g/week of alcohol within 6 months of the screening. (a cup of beer (5%) (250 mL) = 10 g, a shot of soju (20%) (50mL) = 8 g, a glass of wine (!2%) (125 mL) = 12g).
• Who participated other clinical test or took testing bioequivalence drugs in 3 months before the first clinical drug trial.
• Whose blood pressure ≤ 100 or ≥150(systolic blood pressure) or \< 60 or ≥ 100(diastolic blood pressure).
• Who had a medical history of alcohol and drug abuses.
• Who had taken a drug that has a control of metabolic rate (activatioh or inhibithion) in 30 days before the first taking of clinical testing durg.
• WHo smokes more than 20 eigarettes per day.
• Who took prescribed drugs or over-the-conuter durgs in 10 days before taking of very first clinical testing drug.
• Who participated in whole blood donation in 2 months before the first taking of clinical testing drugs or platelet donations in 1 month before the first taking to clinical testing drugs.
• Who has a potent to increase a danger by participating in the clinical trials or sho can interrupt interpretin test results by having serious or chronic medical and mental status or having issues in results of the screening examination.
• Who has a histroy of an extreme sensitivity of drugs that contain the ingredients of Sitagliptin or thiazolidinediones drugs or drugs that contain Rosiglitazone or dugs that have similar effect a Rosiglitazone(Pioglitazone).
• Who has a serious heart failure or a congestive heart failure that must be drug-treated.
• A patient with hepatopathy.

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Chonbuk National University Hospital

Jeonju, South Korea

Location

Related Publications (1)

• Moon SJ, Yu KS, Kim MG. An Assessment of Pharmacokinetic Interaction Between Lobeglitazone and Sitagliptin After Multiple Oral Administrations in Healthy Men. Clin Ther. 2020 Jun;42(6):1047-1057. doi: 10.1016/j.clinthera.2020.04.005. Epub 2020 Apr 30.

  PMID: 32362346 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sitagliptin Phosphate; lobeglitazone

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines

Study Officials

• Min-Gul Kim, MD,PhD

  Chonbuk National University Hospital

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: June 30, 2016
• First Posted: July 11, 2016
• Study Start: April 1, 2016
• Primary Completion: April 1, 2016
• Study Completion: May 1, 2016
• Last Updated: August 9, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)