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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224615

Enrollment

Registered

2019-03-26

Start date

2019-03-28

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

None listed

Interventions

investigational material(s) Generic name etc : Solithromycin INN of investigational material : Solithromycin Therapeutic category code : 614 Antibiotic preparations acting mainly on gram-positive bact

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
pharmacokinetics -	—

Secondary

Measure	Time frame
safety -	—

Countries

Japan

Outcome results