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CTRI Number  CTRI/2023/12/060739 [Registered on: 26/12/2023] Trial Registered Prospectively
Last Modified On: 05/03/2024
Post Graduate Thesis  No 
Type of Trial  BA/BE 
Type of Study    
Study Design  Randomized, Crossover Trial 
Public Title of Study   Comparative bioavailability study of intravenous Propofol MCT-LCT 1% versus Disoprivan® 1% Emulsion in healthy, adult subjects under fasting conditions. 
Scientific Title of Study   An open label, balanced, randomized, single-dose, two treatment, two-sequence, two period, crossover, comparative bioavailability study of intravenous Propofol MCT-LCT 1% versus Disoprivan® 1% Emulsion in healthy, adult subjects under fasting conditions. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
Amendment 0.1 dated 26/oct/2023  Protocol Number 
BXU598007 Original Protocol dated 20/Oct/2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sandeep Singh 
Designation  Vice President - Clinical Operations 
Affiliation  CBCC Global Research 
Address  6th Floor, TURQUOISE-4, Near Shantipura circle, Ahmedabad-382210, Gujarat, India.

Ahmadabad
GUJARAT
382210
India 
Phone  9637555304  
Fax    
Email  sandeep.singh@cbccusa.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sandeep Singh 
Designation  Vice President - Clinical Operations 
Affiliation  CBCC Global Research 
Address  6th Floor, TURQUOISE-4, Near Shantipura circle, Ahmedabad-382210, Gujarat, India.

Ahmadabad
GUJARAT
382210
India 
Phone  9637555304  
Fax    
Email  sandeep.singh@cbccusa.com  
 
Details of Contact Person
Public Query  
Name  Dr Sandeep Singh 
Designation  Vice President - Clinical Operations 
Affiliation  CBCC Global Research 
Address  6th Floor, TURQUOISE-4, Near Shantipura circle, Ahmedabad-382210, Gujarat, India.

Ahmadabad
GUJARAT
382210
India 
Phone  9637555304  
Fax    
Email  sandeep.singh@cbccusa.com  
 
Source of Monetary or Material Support  
Baxter Healthcare Corporation One Baxter Parkway Deerfield, IL 60015, USA  
 
Primary Sponsor  
Name  Baxter Healthcare Corporation 
Address  One Baxter Parkway Deerfield, IL 60015, USA  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NA  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 Manish Agarwal   Medilink Hospital Research Centre  Near Shyamal Cross Road, 132 feet Ring Road, Satellite, Ahmedabad-380015, India
Ahmadabad
GUJARAT 		 9825443397

medilinkhospital@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Medilink Hospital Research Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy, adult subjects under fasting conditions 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Disoprivan® 1% (containing propofol 10 mg/mL) Emulsion zur Injektion/Infusion, manufactured by AstraZeneca GmBH  Dose: 1500 μg/kg in 30 minutes Frequency: Two times in a Month Route of Administration: Intravenous Duration of Therapy: The duration from the screening visit until the end of study assessment  
Intervention  Propofol MCT-LCT 1% emulsion (containing propofol 10 mg/mL) of Baxter   Dose: 1500 μg/kg in 30 minutes Frequency: Two times in a Month Route of Administration: Intravenous Duration of Therapy: The duration from the screening visit until the end of study assessment  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  The subjects who qualify for the study should meet the following inclusion criteria:
1. Male or non-pregnant female subjects, aged 18 to 55 years (inclusive of both).
2. Body mass index between 18.5 to 30.0 kg per m2, (both extremes included) with a minimum weight of 50 kg.
3. Healthy subjects as determined by personal medical history, clinical examination, and laboratory examinations within clinically acceptable normal ranges.
4. Subjects having clinically acceptable 12-lead electrocardiogram (ECG).
5. Subjects having clinically acceptable echocardiogram at screening.
6. Subjects having clinically acceptable chest X-Ray (posteroanterior view).
7. Subjects having negative urine screen for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine, and morphine).
8. Subjects having negative alcohol urine test.
9. Subjects having negative urine cotinine test.
10. Subjects willing to adhere to protocol requirements and to provide written informed consent.
11. For male subjects
Subjects willing to follow approved birth control methods (a double barrier method) for the duration of the study as judged by the investigator(s), such as condom with spermicide, condom with diaphragm, or abstinence. Subjects should also not donate sperm during this time.
12. Subjects having negative urine pregnancy test at screening and negative Serum β-hCG pregnancy test on admission day of Period 1 and Period 2 (only for female subjects).
13. For Female subjects:
Female of childbearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as intrauterine device (IUD), abstinence or double barrier contraception, i.e., condom + diaphragm, condom + spermicidal or foam.
Postmenopausal for at least 1 year, or if less than 1 year, then following acceptable contraceptive measures as mentioned above.
Surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject).
 
 
ExclusionCriteria 
Details  The subjects who qualify for the study should not meet any of the following exclusion criteria:

1. Hypersensitivity to Propofol or related class of drugs or to Pantoprazole, Ondansetron or to any excipients used in the formulation or to peanuts or soya, eggs or heparin.
2. History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, uro-genital, neurological or psychiatric disease or disorder.
3. Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 3 months prior to dosing of Period 1.
4. History or presence of alcoholism or drug abuse.
5. History or presence of smoking or consumption of tobacco products within the past year.
6. History or presence of asthma, urticaria, or other significant allergic reactions.
7. History or presence of urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma within the past 3 years.
8. History or presence of significant gastric and or duodenal ulceration within the past 3 years.
9. History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumour.
10. History or presence of cancer, history of basal or squamous cell carcinoma.
11. Difficulty with donating blood.
12. Difficulty with swallowing solids like tablets or capsules.
13. Use of any prescribed or over the counter (OTC) medication, including herbal medicinal and vitamin products during the last one month prior to first dosing of study.
14. Major illness that required hospitalisation during the past 3 months.
15. Volunteers who have donated blood (1 unit) within 90 days prior to the first dose of the study drug or have blood loss, excluding volume drawn at screening (more than 100 mL within 30 days; more than 200 mL within 60 days) prior to first dose of the study or have received a known investigational drug within 5 elimination half-life of the administered drug prior to the first dose of the study drug.
16. Refusal to avoid the use of xanthine-containing food or beverages (chocolates, tea, coffee, or cola drinks) for 96h prior to dosing, until after the last blood sample collection in each study period.
17. Refusal to avoid the use of grapefruit or grapefruit juice for 96 hours prior to dosing, until after the last blood sample collection in each study period.
18. Positive screening test for anti-HBc, IgM, HIV, Hepatitis B, and or Hepatitis C.
19. Subjects with creatinine clearance less than 90 mL per min as estimated by using the Cockcroft-Gault equation.
20. History or presence of significant easy bruising or bleeding.
21. History or presence of significant recent mental or physical trauma that led to extensive medical care.
22. Subjects who have been on an abnormal diet regimen (e.g., Keto, paleo etc., or any new diet regimen that could change metabolic activity), during the 4 weeks preceding the study.
23. Subjects without visible and accessible superficial veins in antecubital and forearm areas.
24. Subjects with systolic blood pressure less than 100 mm Hg or more than 140 mm Hg.
25. Diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg.
26. Pulse rate less than 60 per minute or more than 100 per minute.
27. Oral temperature less than 96.6 °F or more than 99.0 °F.
28. Respiratory rate less than 12 per minute or more than 20 per minute.
29. Lactating women (currently breast feeding).
30. Use of hormonal contraceptives either oral or implants
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To demonstrate bioequivalence between the test product: single intravenous (IV) dose 1500 μg/kg of Propofol MCT-LCT 1% emulsion (containing propofol 10 mg/mL) of Baxter and the reference product: Disoprivan® 1% Emulsion zur Injektion/Infusion, (manufactured by AstraZeneca GmBH) in healthy, adult subjects under fasting conditions.  A total number of 26 blood samples to be collected over 48 hours.

 
 
Secondary Outcome  
Outcome  TimePoints 
To demonstrate bioequivalence between the test product single intravenous (IV) dose 1500 micro g per kg of Propofol MCT-LCT 1% emulsion (containing Propofol 10 mg per mL) of Baxter & the reference product Disoprivan 1% Emulsion zur Injektion or Infusion, (manufactured by AstraZeneca GmBH) in healthy, adult subjects under fasting conditions.  Safety will be assessed with adverse events (AEs) (including any clinically significant findings from physical examinations, monitoring of vital signs & ECG 
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
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)   01/01/2024 
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="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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 is an open-label, balanced, randomized, single-dose, 2-treatment, 2-sequence, 2-period, crossover, comparative bioavailability study comparing Propofol Baxter 10 mg/mL(test product) and Disoprivan® (reference product) in healthy, adult subjects under fasting conditions. The secondary objective is to monitor the safety and tolerability after a single IV dose administration of the test product on subjects.

It is planned to enroll 66, healthy, adult subjects to be randomized to 2 treatment sequence groups, in order to have data for at least 57 evaluable subjects. Each subject will participate in a screening visit, which may take place up to 28 days prior to product administration. Eligible, enrolled subjects will be admitted to the clinical unit before dosing to undergo pre-dose procedures. Subjects will be randomized to receive a single dose of either the test drug in Period 1 followed by the reference drug in Period 2 or vice versa. 
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