NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JAPIC ID: JapicCTI-194685

Registered date:26/03/2019

An Open-label, One-sequence Crossover Study of Solithromycin to Evaluate the Effects on the Pharmacokinetics of Rosuvastatin Calcium in Healthy Adult Subjects

Basic Information

Recruitment status complete
Health condition(s) or Problem(s) studied-
Date of first enrollment28/3/2019
Target sample size14
Countries of recruitmentJapan
Study typeINTERVENTIONAL
Intervention(s)Intervention name : Solithromycin INN of the intervention : Solithromycin Dosage And administration of the intervention : Oral Multiple Dose Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : -

Outcome(s)

Primary Outcomepharmacokinetics -
Secondary Outcomesafety -

Key inclusion & exclusion criteria

Age minimum20
Age maximum55
GenderBOTH
Include criteria1. Japanese healthy subjects between 20 and 55 years of age 2. BMI between 18.0 and 30.0 kg/ m2 3. Understand the requirements of the study and voluntarily consent to participate in the study
Exclude criteria1. Have a history or presence of clinically significant cardiovascular, dermatologic, endocrine, gastrointestinal, hematologic, hepatic, immunologic, neurologic, oncologic, psychiatric, pulmonary, or renal disease or any other condition, which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results 2. Have a history of allergy to macrolide antibiotics or statin drugs

Related Information

Contact

public contact
Name FUJIFILM Toyama Chemical Co., Ltd. Development Coordination Department
Address
Telephone
E-mail https://www.fujifilm.co.jp/form/fftc/ja/general/input.php?id=FFTCClinicalEn
Affiliation
scientific contact
Name FUJIFILM Toyama Chemical Co., Ltd. Development Coordination Department
Address
Telephone
E-mail https://www.fujifilm.co.jp/form/fftc/ja/general/input.php?id=FFTCClinicalEn
Affiliation