Hypercholesterolemia
Conditions
Interventions
Single-dose administration of K-924 HD tablets (pitavastatin Ca 4 mg / ezetimibe 10 mg) under fasting conditions, or combined single-dose administration of pitavastatin 4 mg tablets and ezetimibe 10
Sponsors
Tanigawa Ryohei
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: (1)Participants who have provided written informed consent to participate in this study prior to the conduct of any study-specific observations or examinations. (2)Healthy adult males. (3)Participants aged between 18 and 35 years at the time of consent. (4)Participants with a BMI of at least 18.5 kg/m2 and less than 30.0 kg/m2 at the time of screening.
Exclusion criteria
Exclusion criteria: (1)Participants judged by the principal investigator or sub-investigator to have a clinically significant history of allergy to drugs or investigational products requiring treatment (e.g., anaphylactic shock). (2)Participants with hypersensitivity disorders (excluding those with asymptomatic hay fever). (3)Participants who have used drugs (including over-the-counter drugs) or supplements within 4 weeks prior to administration of the investigational product in Period 1, or who require such use during the study period. (4)Participants who have donated 200 mL or more of whole blood within 4 weeks prior to screening, 400 mL or more of whole blood within 12 weeks prior to screening, or any blood components (plasma or platelets) within 2 weeks prior to screening. (5)Participants who have participated in another clinical trial and received an investigational product other than placebo within 16 weeks prior to administration of the investigational product, or who will participate in another clinical trial concurrently with this study. (6)Participants with a history of alcohol or drug dependence. (7)Participants with malabsorption or a history thereof, or who have undergone gastrointestinal surgery that may affect absorption (excluding appendectomy and hernia repair). (8)Participants who tested positive for HBs antigen, HCV antibody, HIV antigen/antibody, or syphilis serological test (9)Participants otherwise judged by the principal investigator or sub-investigator to be unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters (Cmax and AUC0-t) of pitavastatin (unchanged form) and ezetimibe (total ezetimibe) following a single oral administration of K-924 HD tablets under fasting conditions, compared with those following a single concomitant administration of pitavastatin 4 mg and ezetimibe 10 mg under fasting conditions | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Plasma Drug Concentrations -Pitavastatin: Unchanged form, lactone form -Ezetimibe: Unconjugated form, total ezetimibe, glucuronide conjugate (2) Pharmacokinetic Parameters in Plasma -Pitavastatin (unchanged form) and ezetimibe (unconjugated form):Cmax, AUC0-t, AUC0-inf, Tmax, t1/2, MRT0-t, MRT0-inf, Kel, CL/F, Vd/F -Pitavastatin (lactone form), ezetimibe (total ezetimibe, glucuronide conjugate):Cmax, AUC0-t, AUC0-inf, Tmax, t1/2, MRT0-t, MRT0-inf, Kel | — |
Contacts
Public ContactContact for clinical trial information
Kowa Company, Ltd.
Outcome results
None listed