Exploratory trials evaluating the pharmacokinetics of Quinidine and Verapamil after oral administration in healthy male subjects

Exploratory trials evaluating the pharmacokinetics of Quinidine and Verapamil after oral administration in healthy male subjects - Exploratory trials evaluating the pharmacokinetics of Quinidine and Verapamil after oral administration in healthy male subjects

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004094

Enrollment

Registered

2010-09-01

Start date

2010-09-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy male subjects

Interventions

Quinidine,Verapamil,Fexofenadine,Midazolam,Celiprolol and Itraconazole

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Key criteria to be considered for this study: (1)Healthy male subjects (2)The subject is capable of giving written consent prior to screening. (3)The subject aged between 20 and 45 years inclusive at screening. (4)The subject has a body mass index in the range of 17.6 to 28.0 kg/m2. (5)The subject is able to abstain from smoking during the hospitalization.

Exclusion criteria

Exclusion criteria: The following subjects shall be excluded from this study: (1)The subject has any medical history that is not considered as eligible for inclusion in this study by the investigator. (2)The subject has the disease which needs a treatment at present. (3)The subject is currently participating in another clinical study and is exposed to an investigational drug. (4) The subject has any medical history of known allergy or hypersensitivity to quinidine, verapamil, fexofenadine, midazolam, celiprorol and itraconazole. (5) The subject has donated whole blood">400mL" within the previous 3 months or ">200mL" within the previous 1 month, and components of blood(apheresis) within the previous 2 weeks. (6) The subject has hypersensitivity to any drugs and foods. (7) The subject has a history or current conditions of drug abuse or alcoholism. (8)The subject is positive for HBs antigen, syphilis, HCV antibody, HIV antigen/antibody. (9)The subject has any clinically relevant abnormality on vital sign, clinical laboratory test, ECG and medical examination. (The subject who admitted participation in this study in the judgement of investigator excludes.) (10)Any subjects considered to be unsuitable for the study by the reseacher.

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics of Quinidine and Verapamil	—

Countries

Japan

Contacts

Public ContactMasaaki Mochii

Tsukuba International Clinical Pharmacology Clinic Clinical Trial Project Office

m-mochii@tsukuba-icp.jp029-839-1150

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026