Healthy Volunteers
Conditions
Brief summary
The purpose of this study is to evaluate the safety and tolerability of nemonoxacin in healthy Chinese volunteers.
Detailed description
Single dose study: evaluate safety and tolerability of oral nemonoxacin 125 mg, 250mg, 500mg, 750mg, and 1000mg. Multiple dose study: evaluate PK profile of oral doses of 500mg or 750mg nemo after consecutive 10 days.
Interventions
DRUGNemonoxacin
oral once daily
Sponsors
TaiGen Biotechnology Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy males and females, aged between 18 and 45 during screening * Male volunteers who are capable of taking double-barrier contraception measures during the test (spermicide gel plus condom, for instance) until the end of the clinical study and do not cause their spouses to conceive within three months after the last administration of the medication; if the subjects are females, they shall not become pregnant during the test and within three months after the study * No use of tobacco or nicotine product within 3 months prior to this study * BMI 19-25 * Willing to abstain from coffee and any caffeine drink during the study * Voluntarily sign the informed consent
Exclusion criteria
* History of diabetes, or cardiovascular, hepatic or renal disease * Active digestive disease (e.g. diarrhea) * Central nervous disease or psychiatric disorders * Had surgery or trauma within 6 months prior to this study * Alcohol or drug abuse * HIV, HBV or HCV positive * Used any prescribed drug (including traditional chinese medicine) within 14 days prior to the study * Donated 400ml of blood or plasma within 3 months prior to this study * Have an abnormal laboratory examination value that exceeds the normal range by 10% * Drug allergies * Have cardiac disorders or have a family history of cardiac disorders * Have abnormal 12-lead ECG during screening * Pregnant or lactating * Participated in any study within 3 months prior to this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum tolerated single oral dose of nemonoxacin in healthy Chinese volunteers | 7 days |
| Pharmacokinetic profile of single oral dose of nemonoxacin in healthy Chinese volunteers | 7 days |
| Pharmacokinetic profile of repeated oral doses of nemonoxacin in healthy Chinese volunteers | 17 days |
Countries
China
Outcome results
None listed