The effect of food on the pharmacokinetics of JLP-1310

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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CRIS

Registry ID

KCT0002625

Enrollment

Registered

2018-01-04

Start date

2017-08-18

Completion date

Unknown

Last updated

2019-03-11

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

Conditions

None listed

Interventions

Drug : Group1. Drug: JLP-1310, Fasted followed by fed In period 1, the subjects will receive an oral pill of JLP-1310 under fasted condition. There will be a washout period of 14 days between each p

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1.Healthy male volunteer, age is 19 to 45 years. 2.Body weight is over 55kg, The result of Body Mass Index(BMI) is not less than 18.0 kg/m2 , no more than 29.0 kg/m2 3. A person who is determined to be eligible for the test through a physical examination or an interview conducted pursuant to this clinical trial plan. In other words, there is no congenital or chronic disease, 4.Those who have been judged to be eligible for the clinical laboratory tests such as hematology test, blood chemistry test, urine test, urine test, serology test conducted according to this clinical trial plan. 5. Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial and who has the ability and willingness to participate the whole period of trial

Exclusion criteria

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.Low blood pressure(Systolic BP = 150mmHG or Diastolic BP = 95mmHg), Hypertension(Systolic BP = 100mmHG or Diastolic BP = 55mmHg)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.

Design outcomes

Primary

Measure	Time frame
Cmax, AUClast of Metformin, Rosuvastatin	—

Secondary

Measure	Time frame
0 h(pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 h	—

Countries

Korea, Republic of

Contacts

Public ContactSang Heon Cho

Inha University Hospital

cptdoctor@gmail.com+82-32-890-1122

Outcome results