Investigate the Effect of Food on the Pharmacokinetics of JLP-1310 in Healthy Male Volunteers

Diabetes Clinical Trial

Official title:

A Randomized, Open-label, Single Dose, Crossover Study to Investigate the Effect of Food on the Pharmacokinetics of JLP-1310 in Healthy Male Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02449187
• Other study ID #: JLP-1310-102-FE
• Status: Completed
• Phase: Phase 1
• First received: May 13, 2015
• Last updated: March 28, 2018
• Start date: August 2, 2017
• Est. completion date: March 9, 2018

Study information

• Verified date: March 2018
• Source: Jeil Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A randomized, open-label, single dose, crossover study to investigate the effect of food on the pharmacokinetics of JLP-1310 in healthy male volunteers.

Description:

A randomized, open-label, single dose, crossover clinical trial.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 9, 2018
• Est. primary completion date: September 15, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

1. Healthy male volunteer, age is over 19 years

2. Body weight is over 55kg, The result of Body Mass Index(BMI) is not less than 17.5 kg/m2 , no more than 30.5 kg/m2

3. Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial

4. Subject who has the ability and willingness to participate the whole period of trial

Exclusion Criteria:

1. Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system.

2. Subjects who are allergic to investigational drug.

3. Subjects who have a medical history which can affect the clinical trial.

4. Hypertension(Systolic BP = 140mmHG or Diastolic BP = 90mmHg), Liver enzyme (AST, ALT) level exceeds the maximum normal range more than one and a half times.

5. History of drug abuse or positive drug screening.

6. Participation in other drug studies within 3 months prior to the drug administration.

7. Whole blood donation within 60 days, blood component donation within 30 days or who got transfusion within 30days.

Related Conditions & MeSH terms

• Diabetes
• Hyperlipidemia
• Hyperlipidemias
• Hyperlipoproteinemias

Intervention

Drug:
• JLP-1310, Fasted followed by fed
In period 1, the subjects will receive an oral pill of JLP-1310 under fasted condition. In period 2, the subjects will receive an oral pill of JLP-1310 under fed condition.
• JLP-1310, Fed followed by fasted
In period 1, the subjects will receive an oral pill of JLP-1310 under fed condition. In period 2, the subjects will receive an oral pill of JLP-1310 under fasted condition.

Locations

Country	Name	City	State
Korea, Republic of	Inha University Hospital	Incheon

Sponsors (1)

Lead Sponsor	Collaborator
Jeil Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax		48 hours from baseline
Primary	AUC(last)		48 hours from baseline
Secondary	AUC(inf)		48 hours from baseline
Secondary	Tmax		48 hours from baseline
Secondary	T1/2		48 hours from baseline
Secondary	CL/F		48 hours from baseline
Secondary	Vd/F		48 hours from baseline