An Open-label, One-sequence Crossover Study of Solithromycin to Evaluate the Effects on the Pharmacokinetics of Metformin Hydrochloride in Healthy Adult Subjects
Phase 1
Completed
- Conditions
- -
- Registration Number
- JPRN-jRCT2080224615
- Lead Sponsor
- FUJIFILM Toyama Chemical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 14
Inclusion Criteria
1. 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
Exclusion Criteria
1. 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 biguanides
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method