An Open-label Study Investigating the Pharmacokinetic Profile and Safety of Single Oral Dose of Budesonide Prolonged Release Tablets 9mg (CortimentÂ® MMX) in Healthy Indian Subjects under Fasting Condition.

Dr Uday Harle0 sites24 target enrollmentTBD

Overview

Phase: 未知
Intervention: Not specified
Conditions: Not specified
Sponsor: Dr Uday Harle
Enrollment: 24
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

TBD

End Date

September 19, 2019

Last Updated

4 years ago

Study Type

Ba/be

Investigators

Sponsor

Dr Uday Harle

Eligibility Criteria

Inclusion Criteria

•1\. Healthy Indian men and women between18\-45 (both inclusive) years of age (at the time of
•signed/thumb impression informed consent).
•2\. Body mass index (BMI) between 18\.5 kg/m2 and 29\.9 kg/m2 (both inclusive) and body weight
•between 50 kg and 100 kg.
•3\. Negative hepatitis screen including hepatitis B surface antigen and/or HCV antibodies at screening.
•4\. Negative test result for HIV (I \& II) antibody.
•5\. Healthy according to medical history (including surgical history), physical examination, 12\-lead ECG, chest X\-ray recordings (postero\-anterior view), vital sign (sitting blood pressure, pulse rate and body temperature), and laboratory profile of blood and urine at screening.
•6\. Negative serum pregnancy test (for females) at Screening and on Day \-1\.
•7\. Regular intestinal function; no constipation and no diarrhea.
•8\. Has given written informed consent prior to any trial\-related activity is performed.

Exclusion Criteria

•1\. Allergy: Ascertained or presumptive hypersensitivity to the active principle, lecithin (derived from soya oil, peanut oil) and/or other formulationsâ?? ingredients; history of anaphylaxis to drugs or allergic reactions in general, which the Investigator considers may affect the outcome of the trial.
•2\. Diseases: Presence or relevant history of renal, hepatic, gastrointestinal, cardiovascular, haematological, respiratory or any other body system, any recent or ongoing infections or endocrine or neurologic diseases that may interfere with the aim of the trial. Particularly, history of gastrointestinal (GI) diseases, inflammatory bowel disease (IBD), intolerance to lactose; neoplasias.
•3\. Medications: medication, including over\-the\-counter (OTC) and CYP3A4 inducers/inhibitors or
•herbal medication, during 2 weeks or five half\-lives of the drug, whichever is longer, prior to screening; in particular, drugs affecting GI physiology. Allowed medications included
•acetaminophen/paracetamol and cromoglycate eye drops according to label, hormonal contraceptives for fertile women.
•4\. Previous or current budesonide treatment
•5\. Use of live vaccine within 4 weeks prior to dosing.
•6\. Life style: history (within the last two years) or present abuse of drug, alcohol \[defined as regular intake of more than 14 units weekly for men /7 units weekly for women \- one unit of alcohol equals about 300 mL of beer or lager, one glass (100 mL) of wine, or 25 mL spirits].
•7\. Current smokers or subjects who have smoked within last six months prior to start of the study.
•8\. Consumption of Grapefruits or its products within a period of one\-week prior to receiving the study drug.