The Study of Pharmacokinetic Interactions Between HL237 and Tacrolimus

• Status: Active, not recruiting
• Trial end date: 2021-01-01
• Target enrollment: 0
• Participant gender: Male

Summary

This study aims to evaluate the pharmacokinetic interaction between HL237 and tacrolimus in healthy male subjects.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hanlim Pharm. Co., Ltd.
• Treatments: Tacrolimus

Criteria

Inclusion Criteria:

• Healthy male, 19 years ≤ age ≤ 45

• Body weight ≥ 50kg and 18.5 ≤ BMI ≤ 29.9kg/m2

• Subjects are agree to use contraceptives that protocol suggest and not provide sperm for up to 2 months after the last administration of the investigational drug

• Volunteer

Exclusion Criteria:

• Subject with serious cardiovascular, respiratory, hepatology, renal, hematologic, gastrointestinal, immunologic, dermal, neurologic, or psychological disease or history of such disease

• Subject with symptoms of acute disease within 28 days prior to investigational products dosing

• Subject with medical history which able to affect absorption, distribution, metabolism and excretion of drug

• Subject with hypersensitive reaction to following drug or history of clinically significant hypersensitive reaction to following drug

• Calcineurin inhibitor or Macrolides

• HL237

• Subject with clinically significant active chronic disease

• Subject with genetic deficiency such as galactose intolerance, Lapp lactose deficiency or glucosegalactose malabsorption

• Subjects who showed one or more of the following in a screening test including a retest

• AST, ALT > UNL (upper normal limit) x 2.5

• Creatinine clearance =< 80mL/min (Cockcroft-Gault GFR = (140-age) * (Wt in kg) / (72 * Cr))

• Results of ECG, QTc > 450 msec

• Positive test results for hepatitis B virus surface antigen, anti-hepatitis C virus antibody, anti-Human Immunodeficiency virus antibody or venereal disease research laboratory test

• Use of any prescription medication within 14 days prior to study medication dosing

• Use of any over-the-counter(OTC) medication within 7 days prior to study medication dosing

• Subject with clinically significant allergic disease (except for mild allergic rhinitis and mild allergic dermatitis that are not needed to administer drug)

• Subject who is not able to taking standard meals provided by the institution

• Subject with whole blood donation within 60 days, component blood donation within 20 days

• Subjects receiving blood transfusion within 30 days prior to study medication dosing

• Participation in any clinical investigation within 6 months prior to study medication dosing

• Use of any medication effected on drug enzyme induction or inhibition such as barbitals within 30 days prior to study medication dosing

• Subjects who have continuously consumed grapefruit juice or caffeine (grapefruit juice or caffeine > 5 cups/day), or who can't refrain from intake during hospitalization

• Subjects who have continued to drink alcohol (alcohol> 30 g/day) or who can't quit drinking during hospitalization

• Severe heavy smoker(cigarette > 10 cigarettes per day) or subjects who can't quit smoking during hospitalization

• Subjects that the investigator deems unsuitable for participation in the clinical trial due to laboratory test results or other excuse such as non-responding to request or instruction by investigator