none Healthy volunteer
Conditions
Interventions
Three different dosing patterns will be compared within the same subject. The order of administration and method of administration will be uniform.
Phase 1: One 40 mg tablets of verapamil hydrochlorid
Pharmacokinetics
Sponsors
Sambe Takehiko
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: (1) Age: between 20 and 40 years old at the time of obtaining consent. (2) Gender: male (3) BMI (Body Mass Index: kg/m^2) is between 18.5 and 28.5 (rounded to the first decimal place). (4) Those who have the capacity to give consent, comply with the rules and regulations during participation in the study, undergo the preliminary examination specified in the study protocol, and report subjective symptoms. (5) Those who are judged to be healthy and eligible to participate in this study by the physician in charge of the research at the preliminary examination specified in the research protocol.
Exclusion criteria
Exclusion criteria: (1) Subjects with clinically problematic ECG abnormalities that may affect the safety of this study. (2) Patients with a history of drug abuse/dependence, alcohol abuse/dependence, cardiac, hepatic, renal, pulmonary, ocular, or hematologic disease that may affect the evaluation and safety of this study (3) Those who are taking drugs (including dietary supplements) that may affect the evaluation and safety of this study. (4) Those with a history of drug allergy. (5) Those who have been participating in other clinical trials for less than 3 months. (6) Others who are judged by the investigator to be ineligible for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters of verapamil hydrochloride in plasma (AUC0-24, Cmax) | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters of verapamil hydrochloride in plasma (t1/2, tmax) | — |
Contacts
Public ContactKakei Ryu
Showa University Clinical Research Institute for Clinical Pharmacology and Therapeutics
Outcome results
None listed