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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04633733
Other study ID # HL237-103
Secondary ID
Status Active, not recruiting
Phase Phase 1
First received
Last updated
Start date August 22, 2020
Est. completion date January 2021

Study information

Verified date November 2020
Source Hanlim Pharm. Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

To evaluate the pharmacokinetic interaction by comparing of pharmacokinetic parameters when administered HL237(or tacrolimus) between with tacrolimus(or HL237) and without tacrolimus(or HL237).


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 24
Est. completion date January 2021
Est. primary completion date September 24, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 19 Years to 45 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
HL237 tablet
HL237 400mg will be administered orally twice a day.
tacrolimus capsule
tacrolimus 5mg will be administered orally once a day.

Locations

Country Name City State
Korea, Republic of The Korea Univertisy Anam Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Hanlim Pharm. Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Peak plasma concentration at steady state(Cmax,ss) of HL237 Comparison of pharmacokinetic parameters between when administered tacrolimus with HL237 and without HL237 0(before dosing), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 hour(after dosing) on day 21 and day 22
Primary Area under the plasma concentration versus time curve during a dosage interval(AUCt) of HL237 Comparison of pharmacokinetic parameters between when administered tacrolimus with HL237 and without HL237 0(before dosing), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 hour(after dosing) on day 21 and day 22
Primary Peak whole-blood concentration(Cmax) of tacrolimus Comparison of pharmacokinetic parameters between when administered tacrolimus with HL237 and without HL237 0(before dosing), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72hour(after dosing) on day 1 and day 22
Primary Area under the whole-blood concentration versus time curve from time zero to time of last measurable concentration(AUClast) of tacrolimus Comparison of pharmacokinetic parameters between when administered tacrolimus with HL237 and without HL237 0(before dosing), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72hour(after dosing) on day 1 and day 22
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