An Open-label, Single or Multiple-dose, Fixed-sequence, 3-treatment, 3-Period Phase 1 Study to Evaluate the Pharmacokinetic/Pharmacodynamic Interactions and Safety Between ID1801 and ID1803 in Healthy Male Subjects
| Registry | NCT04185090 |
|---|---|
| Status | Unknown |
| Phase | Phase 1 |
| Study type | Interventional; non randomized, sequential, masking: none, treatment |
| Enrollment | 30 (Estimated) |
| Sponsor | IlDong Pharmaceutical Co Ltd (Industry) |
| Conditions | Hypertension, Dyslipidemias |
| Interventions | ID1803, ID1801, ID1803+ID1801 (Combination product) |
| Dates | start 2020-02-01 (estimated), primary completion 2020-04-01 (estimated), completion 2020-04-01 (estimated), first posted 2019-12-04, last updated 2019-12-26 |
Related Papers Related Patents Related Grants Related Experts
All trials for Hypertension All trials for Dyslipidemias All trials of ID1803 All trials of ID1801
This study is designated to evaluate the pharmacokinetic interactions of valsartan, amlodipine besylate, rosuvastatin, and ezetimibe in healthy male volunteers.
An Open-label, Single or Multiple-dose, Fixed-sequence, 3-treatment, 3-Period phase 1 study to Evaluate the Pharmacokinetic/Pharmacodynamic Interactions and Safety between ID1801 and ID1803 in Healthy Male Subjects
| Arm | Type | Interventions | Description |
|---|---|---|---|
| ID1801 | Active comparator | Combination Product: ID1801 | qd daily for 6days Intervention: Drug: administration of ID1801 for 6days. |
| ID1803 | Active comparator | Combination Product: ID1803 | qd daily for 10days Intervention: Drug: administration of ID1803 for 10days. |
| ID1801 and ID1803 | Experimental | Combination Product: ID1803+ID1801 | qd daily for 7days Intervention: Drug: administration of ID1801 and ID1803. |
Sex: Male, ages: 19 Years to 45 Years, accepts healthy volunteers
Inclusion Criteria: * Healthy adult male volunteers aged 19 to 45 years * Subjects who have over 50kg and BMI more than 18.5kg/m2 and less than 29.9kg/m2 * Males must be agree to practice a medically acceptable method* of birth control and will not donate sperm during the study. * Subjects who provided written informed consent to participate in this study and voluntarily taken part in during the entire study period Exclusion Criteria: * Subject with serious active cardiovascular, respiratory, hepatologic, renal, hematologic, gastrointestinal, immunologic, dermal, neurologic, or psychological disease or history of such disease * Subject with symptoms of acute disease within 28days prior to study medication dosing * Medical history or evidence that can affect absorption, distribution, metabolism and excretion of a given drug * Drugs or other drugs (aspirin, antibiotics, etc.) that contain the following drug categories or components of the same strain have an overactive or clinically significant history of hypersensitivity: * Subject with a history of drug abuse or urinalysis positive * Subject with clinically significant active chronic disease * Subject with genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption. * Genetic myopathic disorder or related family history * Positive test results for HBs Ab, HCV Ab, Anti HIV(AIDS), RPR Ab * Subject with clinically significant allergic disease (except for mild allergic rhinitis and mild allergic dermatitis that are not needed to administer drug) * Subject who cannot take standard meal in hospitalization * Present history of hypothyroidism or clinically significant assay * Subjects who donated whole blood or partial blood within 2 or 1 month, respectively, prior to the first administration. * Subject taking inducer or inhibitor of drug metabolism enzyme such as barbital within 30days prior to study medication dosing * Smokers whose average daily smoking amount exceeds 10 cigarettes per day within 3 months before the first dosing day and those who can't quit from 48 hours before dosing to the time of the last blood sampling. * Subjects who judged ineligible by the investigator