Comparative bioavailability study of intravenous Propofol MCT-LCT 1% versus Disoprivan® 1% Emulsion in healthy, adult subjects under fasting conditions.
- Registration Number
- CTRI/2023/12/060739
- Lead Sponsor
- Baxter Healthcare Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
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 ß-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).
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 th
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method