None listed
Conditions
Interventions
Intervention1: Troxipide 100 mg: Troxipide 100 mg orally single dose in a day
Control Intervention1: APLACE 100 mg (Troxipide 100 mg): APLACE 100 mg orally single dose in a day
Sponsors
Emcure Pharmaceutical Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1 Age and Sex: Adult, Male between 18 to 45 yrs 2 Height and Weight: between 15% as per Life Insurance Corporation of India table for ideal height and weight 3 Smoking: Nonsmoker 4 Physical Examination: No evidence of Underlying disease 5 Clinical Examination: No evidence of medical disorders or impairments (Hepatic, renal, cardiac, and psychiatric)No vital sigh abnormalities (BP, Pulse etc) 6 Laboratory findings: Non clinical significant abnormal laboratory values during the pre-study screening. No clinical biochemistry, hematology, liver and kidneys function tests and urinalysis in acceptable limits 7 HIV, Hepatitis B: Negative in screening or non reactive 8 Cardiac Function: Acceptable ECG 9 Contraindicated / allergy: No history of contraindication and or allergy to drug or any related compound 10 Concurrent systemic medication: No consumption of drug for two weeks prior to the study 11 Drug/ alcohol abuse: No drug or alcohol abuse
Exclusion criteria
Exclusion criteria: 1 History of hypersensitivity to the study drug or related product 2 significant history or presence of psychiatric, gastrointestinal, liver or kidney disorder/impairments, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of common medication 3 Significant history of asthma, chronic bronchitis or other bronchospastic condition. 4 Significant history or presence of glaucoma, cardiovascular or hematological disease or diabetes or metabolic acidosis or with a known food allergy 5 Any clinical significant illness during the 4 weeks prior to day one of this study or hospitalized during 3 months prior to the commencement of this study 6 Maintenance therapy with any drug or history of drug dependency, alcohol abuse or serious neurological or psychological disease 7 Participation in a clinical trial with an investigation drug within 90 days preceding day one of the current study 8 Use of enzyme modifying drug within 30 days prior to day one of this study 9 Use of any systemic medication (Including OTC preparation)within 14 days proceeding day one of this study 10 Had a depot injection or an implant of any drug 3 months prior to the commencement of this study 11 Donates blood (350 ml)within 3 months prior to the commencement of this study 12 HIV and Hepatitis positive findings
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Troxipide 100 mg is Bioequivalent to APLACE 100 mgTimepoint: 14 days | — |
Secondary
| Measure | Time frame |
|---|---|
| No adverse reactions observed during the study periodTimepoint: 14 days | — |
Countries
India
Contacts
Public ContactDr Shashikumar Menon
Therapeutic Drug Monitoring Laboratory
Outcome results
None listed