None listed
Conditions
Interventions
Intervention1: Itraconazole Oral Soloution: The recommended dosage of traconazole Oral Solution for oropharyngeal
candidiasis is 200 mg (20 mL) daily for 1 to 2 weeks. Clinical signs and symptoms of
o
Sponsors
GC CHEMIE PHARMIE LIMITED
Eligibility
Inclusion criteria
Inclusion criteria: Healthy adult subjects between 18-45 years (both inclusive) of age, having a Body Mass Index between 18.50 â??24.99 kg/m2(both inclusive), healthy according to medical history, clinical examination, laboratory evaluations, 12-lead ECGwith chest X-ray (valid for 01 year), haematology, biochemistry, serology (HIV, VDRL/RPR, HepatitisB and C tests), urine analysis will be performed for all subjects. Subjects preferably should be non-smokers and without a history of alcohol or drug abuse
Exclusion criteria
Exclusion criteria: Known hypersensitivity or idiosyncratic reaction to the study drug or any related drug.History of allergic reaction to heparin.History or presence of any disease or disorder known to influence bone metabolism, compromise the hemopoietin, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal, musculoskeletal or any other body system.Systolic blood pressure less than90 mmHg or more than 140 mmHg at the time of screening. Minor deviations (2-4 mmHg) may be acceptable at the discretion of the physician/investigator.Diastolic blood pressure less than 60 mmHg or more than 90 mmHg at the time of screening. Minor deviations (2-4 mmHg) may be acceptable at the discretion of the physician/investigator.Pulse rate below60 beats/minute or above 100 beats/minute at the time of screening.Respiratory rate below 15 or above 20 breaths per minute.Oral temperature below 96.2oF or above 99.8 o F at the time of screening. Ingestion of any medicine at any time within 14 days prior to IP administration in period I. In any such case subject selection will be at the discretion of the principal investigator.Habit of consuming high caffeine (more than 5 cups of coffee or tea/day).History of dehydration from diarrhea, vomiting or any other reason within a period of 24.00 hours prior to study check-inof each period.An unusual or abnormal diet within 48.00 hours prior to study check-inof each period, whatever reason e.g. because of fasting due to religious reasons.The presence of clinically significant abnormal laboratory values during screening.Use of any recreational drugs or history of drug addiction or testing positive in pre-study urine drug screening and alcohol breath analysis.A history of difficulty with donating blood or having donated blood in the preceding 90 days prior to the start of the study.Subject who has participated in any other clinical study involving drug administration and collection of blood samples in the 90 days preceding the start of the study.Positive HIV, VDRL/RPR, Hepatitis B and C tests.Subjects who have used any drugs or substances known to be strong inhibitors or inducers of Cytochrome P450 enzymes within 14 days prior to IP administration in period I.Prior to check-in of Period-One, complete the Inclusion and Exclusion Criteria Form (Attachment 1 to this protocol) for each volunteer. Only suitable volunteers should be allowed to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the rate and extent of absorption of Itraconazole oral solution (10mg/mL) (T) of Manufactured by G.C. Chemie Pharmie Ltd at Kingston Aqua Industries (P) Ltd, Plot No.3, Bhatoli-Kalan,Industrial Town Ship, Baddi with Sporanox(Itraconazole oral solution) (10mg/mL) (R) Authorization holder Janssen-Cilag Limited, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG UKTimepoint: 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the adverse events and to ensure the safety of the subjects following administration of a single dose of Itraconazole oral solution.Timepoint: 2 MONTHS | — |
Countries
India
Contacts
Public ContactDr Baby ShaliniS
Notrox Research Pvt Ltd
Outcome results
None listed