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CTRI Number  CTRI/2025/11/097344 [Registered on: 13/11/2025] Trial Registered Prospectively
Last Modified On: 31/10/2025
Post Graduate Thesis  No 
Type of Trial  BA/BE 
Type of Study    
Study Design  Randomized, Crossover Trial 
Public Title of Study   A randomized, open-label, two-treatment, four-cohort, two-period, two-sequence, crossover, single-dose, oral comparative pharmacokinetic and bioequivalence study under fasting conditions. 
Scientific Title of Study   A randomized, open-label, two-treatment, four-cohort, two-period, two-sequence, crossover, single-dose, oral comparative pharmacokinetic and bioequivalence study of 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., India in healthy adult male human subjects under fasting conditions. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
ACET-25-002 V00 Date- 30/08/2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shashi Kumar Singh 
Designation  Principal Investigator 
Affiliation  Mediclin Clinical Services Pvt. Ltd 
Address  Mediclin Clinical Services Pvt. Ltd Plot # 2A, Dubagga, Lucknow-226003

Lucknow
UTTAR PRADESH
226003
India 
Phone  9555494381  
Fax    
Email  shashi.singh@mcscro.in  
 
Details of Contact Person
Scientific Query  
Name  Animesh Ghosh 
Designation  Professor 
Affiliation  Birla Institute of Technology 
Address  Birla Institute of Technology, Mesra, Ranchi, Jharkhand - 835215

Ranchi
JHARKHAND
835215
India 
Phone  9007175618  
Fax    
Email  aghosh@bitmesra.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr Shashi Kumar Singh 
Designation  Principal Investigator 
Affiliation  Mediclin Clinical Services Pvt. Ltd 
Address  Mediclin Clinical Services Pvt. Ltd Plot # 2A, Dubagga, Lucknow-226003,

Lucknow
UTTAR PRADESH
226003
India 
Phone  9555494381  
Fax    
Email  shashi.singh@mcscro.in  
 
Source of Monetary or Material Support  
Birla Institute of Technology 
 
Primary Sponsor  
Name  Birla Institute of Technology 
Address  Mesra, Ranchi, Jharkhand - 835215 
Type of Sponsor  Contract research organization 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shashi Kumar Singh  Mediclin Clinical Services Pvt. Ltd  Department- Clinical Pharmacology Unit Ward- III First Floor Mediclin Clinical services Pvt Ltd Plot # 2A, Dubagga, Lucknow-226003, India
Lucknow
UTTAR PRADESH 		 9555494381

shashi.singh@mcscro.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human Ethics Committee Udyaan Health Care Pvt Ltd  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Human Volunteer 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  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, that the tablet should not be crushed or chewed and should be swallowed as a whole. Subject will be provided with at least 240 mL of drinking water for swallowing the tablets. Dose administration was conducted in a sequential manner, with Arm 1 assigned to Cohort 1, Arm 2 to Cohort 2, Arm 3 to Cohort 3, and Arm 4 to Cohort 4, ensuring a structured and balanced study design as per randomization schedule. Two Periods and total duration is 14 days each.  
Comparator Agent  DIAMOX® Tablet (Acetazolamide Tablets I.P. 250 mg)  Acetazolamide - PABA cocrystal Tablet Strength - 50 mg, 125 mg, 200 mg and 250 mg. Dosing Procedure: Instructions will be given to the subject, that the tablet should not be crushed or chewed and should be swallowed as a whole. Subject will be provided with at least 240 mL of drinking water for swallowing the tablets. Dose administration was conducted in a sequential manner, with Arm 1 assigned to Cohort 1, Arm 2 to Cohort 2, Arm 3 to Cohort 3, and Arm 4 to Cohort 4, ensuring a structured and balanced study design as per randomization schedule. Two Periods and total duration is 14 days each.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Male 
Details  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.
 
 
ExclusionCriteria 
Details  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 cases, subject selection will be at the discretion of the Principal Investigator/medical officer.
• Diuretics: Increased risk of hypokalemia and dehydration when used concomitantly with other diuretics.
• Salicylates: Increased risk of severe metabolic acidosis and central nervous system toxicity. Salicylates may potentiate the effect of acetazolamide on bicarbonate loss.
• Antiepileptic drugs: Acetazolamide may alter serum levels of antiepileptics; dosage adjustment may be needed.
• Lithium: Acetazolamide increases lithium excretion, possibly reducing its therapeutic effect.
• Amphetamines: May enhance the toxicity of amphetamines by alkalinizing the urine, thereby reducing their excretion.
• Methenamine: Acetazolamide alkalinizes urine, reducing the antibacterial efficacy of methenamine, which requires an acidic environment to be effective.
• Cardiac glycosides: Electrolyte disturbances (especially hypokalemia) caused by acetazolamide may increase the risk of digoxin toxicity.
• Cyclosporine: Concurrent use may increase the risk of nephrotoxicity.
• Antidiabetic agents: Risk of lactic acidosis may be increased due to renal function alterations caused by acetazolamide.
22. Intake/administration of any prescription, antacids or OTC drug including vitamins and natural supplements within 30 days of Period I admission. In such cases, subject selection will be at the discretion of the Principal Investigator/medical officer.
23. Intake of unusual diet for two weeks prior to admission of period-I and not willing to avoid consumption of such diet till the completion of close-out visit of the study. In such cases, subject selection will be at the discretion of the Principal Investigator/designee.
24. Difficulty in swallowing tablets 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
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. India  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 Outcome  
Outcome  TimePoints 
Safety of the study subjects will also be monitored & evaluated.  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. 
 
Target Sample Size   Total Sample Size="48"
Sample Size from India="48" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/11/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   This study aims to compare the pharmacokinetic and bioequivalence of the Test Product (T: Acetazolamide - PABA cocrystal tablet) of Birla Institute of Technology India with the Reference Product (R: DIAMOX® Tablet (Acetazolamide Tablets I.P. 250 mg)) of Sun Pharma Laboratories Ltd., India. The study will involve 48 subjects, each housed in a clinical facility for at least 12 hours before dosing and remaining in the facility for at least 24 hours after dosing in each period. The study will also monitor and evaluate the safety of the study subjects.
The subjects will be given instructions to swallow the tablets as a whole, with at least 240 mL of drinking water provided. A mouth check will be performed to ensure the subject has swallowed the tablet. After the study, subjects will remain in a sitting position for 04 hours post-dose and only allow necessary movement. Pre-dose and post-dose blood samples will be collected from each subject using pre-labelled K2EDTA containing vacutainers. 
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