Healthy Volunteers
Conditions
Interventions
single dose,
2 arm crossover study,single dose,
2 arm crossover study
Active Comparator Drug,Experimental Drug
Sandostatin,Octreotide-
SBS
Sponsors
Siam Bioscience
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1.Willingness to provide written informed consent prior to participate in the study. 2.Healthy Thai subjects are between 18 to 55 years of age. 3.The Body Mass Index (BMI) ranges from 18 to 25 kg/m2. 4.Comprehensive of the nature and purpose of the study and compliance with the requirement of the entire protocol and allow investigators to draw 10 mL of blood for monitoring subjects’ safety after the completion of the study. 5.Negative urine pregnancy test for women and no breast-feeding. 6.Absence of significant diseases or clinically significant abnormal laboratory values on the laboratory evaluations, medical history or surgery during the screening. Some of the laboratory values e.g. Complete blood count etc. that out of the normal range will be carefully considered by physician.
Exclusion criteria
Exclusion criteria: 1.History or evidence of allergy or hypersensitivity to Octreotide or any related drugs or any of the excipients of this product. 2.Subject with B.P. is Systolic B.P 100 beats per minute. 3.Serum bilirubin greater than 1.5 times the upper limit of reference range 4.Serum creatinine greater than 1.5 times the upper limit of reference range 5.Alanine amino transferase (ALT) or aspartate amino transferase (AST) greater than 2 times the upper limit of reference range (ULRR).* 6.Positive of hepatitis B or C virus. 7.12-lead EKG demonstrating QTc >450 msec, a QRSD >120 msec or with an abnormality considered clinically significant at Screening. 8.History or evidence of heart, renal, hepatic disease, pulmonary obstructive disease, bronchial asthma, hypertension, glaucoma or thyroid disease . 9.Any major illness in the past 3 months or any significant ongoing chronic medical illness. 10.History of psychiatric disorder. 11.History of regular alcohol consumption 12.History of usually smoking 13.High caffeine consumption 14.Positive drug abused test in urine (Benzodiazepines, Marijuana (THC), Amphetamine, Cocaine and Opioids). 15.Receipt of any prescription drug therapy within 14 days or 5 half-lives (whichever longer) preceding the first dose of study medication 16.History of difficulty in accessibility of veins in left and right arm. 17.Blood donation (one unit or 450 mL) within the past 3 months before the study. 18.Participation in any clinical study within the past 3 months before the study. 19.Subjects who are unwilling or unable to comply with the lifestyle guidelines described in this protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameter pre-dose and at 0.083, 0.167, 0.33, 0.5, 0.75, 1, 1.25, 1.50, 1.75,2, 2.5,3,4,5,6,8,10,12,16,24 hour LC-MS/MS method | — |
Secondary
| Measure | Time frame |
|---|---|
| safety of the test and reference formulation pre-dose and at 0.083, 0.167, 0.33, 0.5, 0.75, 1, 1.25, 1.50, 1.75,2, 2.5,3,4,5,6,8,10,12,16,24 hour Lab testing and Physical examination | — |
Countries
Thailand
Contacts
Public ContactDr. Sasitorn Kittivoravitkul
Bio-innova and Synchron Co., Ltd
Outcome results
None listed