None listed
Conditions
Interventions
Intervention1: Acetazolamide - PABA cocrystal tablet: Acetazolamide - PABA cocrystal Tablet
Strength - 50 mg, 125 mg, 200 mg and 250 mg.
Dosing Procedure: Instructions will be given to the subject, t
Sponsors
Birla Institute of Technology
Eligibility
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria in order to be included in the study: 1. Subject’s age should be between 18 ¬– 50 years for male. 2. Subjects who are able to read and write the vernacular language (English/Hindi) and understand the study requirements. 3. Must have provided written informed consent for participation in the study in the subject’s vernacular language (English/Hindi). 4. Minimum weight 50.0 kg for male. 5. BMI 18.50 – 29.50 Kg/m2. 6. Healthy as determined by medical history, physical, clinical and laboratory examination performed within 25 days prior to admission for the first period of the study. 7. In the opinion of the Principal Investigator/Co-Investigator/designee, be able to comply with the study procedures and protocol restrictions.
Exclusion criteria
Exclusion criteria: Subjects must have none of the following criteria in order to be included in the study: 1. Known hypersensitivity (include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute interstitial nephritis, and urticaria) or idiosyncratic reaction to (Acetazolamide) or any substituted benzimidazole and its excipients or similar classes of drugs. 2. Any evidence of significant abnormalities upon physical or clinical examination. 3. Laboratory values, which are significantly different from pre-defined reference ranges and judged clinically significant. 4. Consumption of grapefruit juice/ grapefruit at least 48-hours prior to admission in all period of the study. 5. Clinical symptoms of Cyanocobalamin (Vitamin B-12) Deficiency 6. Any clinically significant abnormality in Chest X-Ray PA view or invalid Chest X-ray PA view (after 01 year of validity). 7. Any clinically significant abnormality in ECG. 8. Regular use of tobacco or nicotine in significant amount in any form (e.g. use of equal to or more than 5 cigarettes a day) or have difficulty in abstaining from [smoking] nicotine use for the entire duration of the study. 9. History of drug dependence or excessive alcohol intake on a habitual basis, or, inability to abstain from alcohol for the entire duration of study. 10. History or presence of significant gastrointestinal, hepatic, renal, cardiovascular, pulmonary, neurological, hematologic, or endocrine disease. 11. History or presence of any chronic illnesses such as arthritis, asthma, epilepsy, hypertension, glaucoma etc. 12. Presence of disease markers of HIV 1 or 2, Hepatitis B or C viruses and syphilis. 13. Positive result for drug(s) of abuse testing (amphetamines, barbiturates, benzodiazepines, tetrahydrocannabinol, morphine, and cocaine) in urine 14. Positive for urine alcohol. 15. History or presence of any psychiatric illness including Symptoms of Depression or mania (Sleep Disturbances, Interest/pleasure reduction, Guilt feelings or thoughts of worthlessness, energy changes/fatigue, concentration/attention impairment, appetite/weight changes, psychomotor disturbances and having thoughts of suicide) and /or intake of any anti-depressant medications. 16. History or presence of any allergic illness including allergic skin diseases, allergic asthma and drug-induced allergy, e.g., NSAIDs. 17. History of intake/administration of any investigational treatment in a clinical study within last 90 days prior to the onset of the study admission of period-I of the study 18. History of significant blood loss (more than or equal to 350 mL) due to any reason, including blood donation within last 90 days prior to admission of period-I of the study. 19. Existence of any surgical or medical condition which in the judgement of principal investigator/designee might interfere with the absorption, distribution, metabolism or elimination of the study drug, or, is likely to compromise the safety of subject. 20. Intake/administration of any enzyme-modifying drugs such as cimetidine, ampicillin, antihistamines, within 30 days of Period I admission. In such cases, subject selection will be at the discretion of the Principal Investigator/medical officer. 21. Intake/administration of drugs which mentioned below have interaction with Acetazolamide within last 30 days of Period I admission. In such
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the pharmacokinetic and bioequivalence of the Test Product [T: Acetazolamide - PABA cocrystal tablet] of Birla Institute of Technology India with Reference Product [R: DIAMOX® Tablet (Acetazolamide Tablets I.P. 250 mg)] of Sun Pharma Laboratories Ltd. IndiaTimepoint: Samples will be collected at Pre-dose (0.00) and 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50. 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00 and 48.00 hours post dose. Samples at 36.00 and 48.00 hours will be collected at ambulatory sample in both Period Base line 4 weeks and 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety of the study subjects will also be monitored & evaluated.Timepoint: Blood pressure time point - pre-dose (0.00) & at 2.00, 4.00, 6.00, 08.00 & 10.00 hours post-dose. All post-dose vital signs through 10.00 hours will be recorded within ± 40 minutes of the scheduled time for each subject in each period. at baseline 4 weeks & 8 weeks. | — |
Countries
India
Contacts
Public ContactDr Shashi Kumar Singh
Birla Institute of Technology
Outcome results
None listed