A Bioequivalence Study of Two Formulations of 400-mg Moxifloxacin (as Hydrochloride) Tablets in Healthy Thai Subjects under Fasting Conditions

Phase 1

• Conditions: Antibiotic; Moxifloxacin, Bioequivalence

• Registration Number: TCTR20200309001
• Lead Sponsor: T.O. Chemicals (1979) Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-09
• Study Completion: 2021-12-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

1.Male/Female must be 18-55 years of age, body mass index (BMI) = 18.0-25.0 kg/m2, inclusive.
2.Must be in good health as determined by medical history, vital signs and physical examination or showing no clinically significant abnormalities in the opinion of clinical investigator
3.Screening ECG without clinically significant abnormalities
4.Screening visit laboratory values of blood test must be within the normal range or showing no clinically significant abnormalities in the opinion of clinical investigator.
5.Urinalysis results within normal limit or showing no clinically significant abnormalities in the opinion of clinical investigator.
6.Must have serum hepatitis B surface antigen (HBsAg) seronegative.
7.Female subjects must have serum B-hCG negative or is not pregnant or breast feeding.
8.Non-smokers (never smoked or no smoking within the previous 1 year).
12.Have the ability to understand the requirements of the study and must voluntarily sign and date an informed consent, approved by an Independent Ethic Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures

Exclusion Criteria

1.Known hypersensitivity to moxifloxacin, other quinolones and its components
2.Past medical history of renal and hepatic insufficiency.
3.Subject has a history of any illness
4.Have history of drug abuse in the opinion of the investigator, as judged by medical history) in the last 12 months.
5.Alcohol abuse or excessive use (in the opinion of the investigator, as judged by medical history) in the last 12 months.
6.Participation in any investigation drug study within 1 month from screening (from the last follow-up visit to the screening).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Moxifloxacin level in plasma 20 time points Pharmacokinetic parameters: AUC0-t, AUC0-inf, Cmax, tmax of moxifloxacin

Secondary Outcome Measures

Name	Time	Method
/A N/A N/A