Clinical Study on Oral Nemonoxacin Malate Capsules

Healthy Volunteers Clinical Trial

Official title:

Phase I Clinical Study on Oral Nemonoxacin Malate Capsules

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01395108
• Other study ID #: TG-873870-C-1
• Status: Completed
• Phase: Phase 1
• First received: July 13, 2011
• Last updated: July 13, 2011
• Start date: January 2008
• Est. completion date: August 2008

Study information

• Verified date: July 2011
• Source: TaiGen Biotechnology Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and tolerability of nemonoxacin in healthy Chinese volunteers.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Nemonoxacin
oral once daily

Locations

Country	Name	City	State
China	Institute of Antibiotics, Huashan Hospital, Fundan University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
TaiGen Biotechnology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated single oral dose of nemonoxacin in healthy Chinese volunteers		7 days	Yes
Primary	Pharmacokinetic profile of single oral dose of nemonoxacin in healthy Chinese volunteers		7 days	Yes
Primary	Pharmacokinetic profile of repeated oral doses of nemonoxacin in healthy Chinese volunteers		17 days	Yes