Moxifloxacin could potentially cause nausea,
Conditions
Interventions
Subjects tried test product.,Subjects tried reference product.
Other,Other
Sponsors
None listed
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: a) Healthy human adult literate subjects between 18-45 years of age (inclusive), having a body mass index (BMI) between 18.5 and 30 kg/m2 (inclusive). b) Subjects who have no evidence of underlying disease during screening and whose physical examination is performed within 21 days prior to study start. c) Subjects whose screening laboratory values, vital signs, ECG and chest X- ray are within normal limits or considered by the physician/Principal Investigator to be of no clinical significance. d) Subjects whose SGPT/SGOT with in the reference range e) Non-smokers or ex-smokers (Non-smokers for at least 3 months) or light smokers (less than I0 cigarettes per day for at least 3 months). f) Informed consent given in written form according to section Il.3 of the protocol. g) Female subjects with child-bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigators i.e. condoms, foams, jellies, diaphragm, intrauterine device (IUD).
Exclusion criteria
Exclusion criteria: a) Have history of cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease. b) Have history of asthma, urticaria or other allergic type reactions after taking any medication. c) Have history of hypersensitivity to Moxifloxacin and any other similar class of drugs or any of its excipients. d) Have history of photosensitivity e) Volunteer with significant alcohol dependence, alcohol abuse or drug abuse within past one year. f) Moderate to heavy smoking (more than 10 cigarettes/day) g) Consumption of tobacco products more than 4 packets/day. h) Have difficulty in swallowing tablet/capsule i) Any clinical illness identifies within 4 weeks before the start of the study j) Subjects with QTc 2: 440ms to be excluded k) Subject who has participated in any other clinical study involving drug administration and collection of blood samples in the preceding 90 days prior to the start of the study. l) Subject has donated blood in the preceding 90 days prior to the start of the study. m) Subject who have positive urine drug screening, Alcohol breath analysis, HIV, VDRLIRPR, Hepatitis B & C tests. n) Subject who have systolic blood pressure less than 100 mm of Hg or more than 140 mm of Hg o) Diastolic blood pressure less than 60 mm of Hg or more than 90 mm of Hg. Minor deviations (2-4 mm Hg) at check-in may be acceptable at the discretion of the physician /investigator p) Female volunteers demonstrating a positive pregnancy screen or currently breast-feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics study 8 time points per patients HPLC-ms/ms | — |
Secondary
| Measure | Time frame |
|---|---|
| Bioequivalences 8 time points Percentage | — |
Countries
India
Contacts
Public ContactChuei Wuei Leong
Consultant of Innovax
Outcome results
None listed