Miyarisan-BM (Clostridium Butyricum Miyairi) 40 mg po tid x 6 months

ursodoxycholic acid, 200mg po tid x 6 months

Biotase 1# [Biodiastase 30mg + lipase 65mg + newlase 10mg]/tab po tid x 6 months

Clostridium Butyricum Miyairi

Gallstones

Gastrointestinal Quality of Life Index

Miyarisan-BM (Clostridium Butyricum Miyairi)

Urso group

Biotase group

Min sheng general hospital

Probiotics for Gallstones in Post-bariatric Surgery Patients：A Prospective Randomized Trial

Probiotics for Gallstones in Post-bariatric Surgery Patients：A Prospective

Min-Sheng General Hospital

Healthy male subjects in this cohort will take part in 4 treatment periods with one of the following treatments in each period. Subjects will receive single dose of all four treatments (one per period) in a random order. Treatment A = 2 mg GSK2256294 capsules, Treatment B = 6 mg GSK2256294 capsules, Treatment C = 18 mg GSK2256294 capsules, Treatment P = Matched Placebo capsules.

Obese adult male smoker subjects in this cohort will take part in 4 treatment periods with one of the following treatments in each period. Subjects will receive single dose of all four treatments (one per period) in a random order. Treatment A = 15 mg GSK2256294 capsules, Treatment B = 40 mg GSK2256294 capsules, Treatment C = 100 mg GSK2256294 capsules, Treatment P = Matched Placebo capsules.

Obese adult male smoker subjects in Cohort 3 will receive single or twice daily dose of GSK2256294 or placebo for 14 days. Dose selection for Cohort 3 will be based on the safety, PK profile and enzyme inhibition obtained in cohorts 1 and 2.

Obese adult male smoker subjects in Cohort 4 will receive single or twice daily dose of GSK2256294 or placebo for 14 days. Dose selection for Cohort 4 will be based on the safety, PK profile and enzyme inhibition obtained in cohorts 1 and 2 as well as safety and PK profile obtained in cohort 3.

Pulmonary Disease, Chronic Obstructive

GSK2256294 capsules will be administered as once daily as single dose 2 mg, 6 mg, 15 mg in Cohort 1 and 15 mg, 40 mg, 100 mg in Cohort 2. GSK2256294 capsules will be administered once or twice daily (cohorts 3 and 4) at the dose determined from the data from Cohort 1 and 2. GSK2256294 capsules will be available in 1, 5, 25 mg dose strength.

GSK2256294

Matching placebo will be administered once daily (cohorts 1 and 2); and once or twice daily (cohorts 3 and 4).

Placebo

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

GSK Investigational Site

A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Doses of GSK2256294 in Healthy Volunteers, and Single and Repeat Doses of GSK2256294 in Adult Male Moderately Obese Smokers

A Single-centre, Randomised, Double-blind, Placebo-controlled, Escalating Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Doses of GSK2256294 in Healthy Volunteers, and Single and Repeat Doses of GSK2256294 in Adult Male Moderately Obese Smokers

Vital signs include systolic blood pressure, diastolic blood pressure, and pulse rate. Vital signs will be collected with the subject semi-supine and after they have been resting for 5 minutes.

12-lead electrocardiograms (ECGs) will be obtained at each time point during the study using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTcF intervals. ECGs will be obtained in the semi-supine position after the subject has been resting for at least 5 minutes.

12-lead ECGs will be obtained at each time point during the study using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTcF intervals. ECGs will be obtained in the semi-supine position after the subject has been resting for at least 5 minutes.

Safety data will include assessments of clinical laboratory tests (hematology, clinical chemistry and urinalysis).

Adverse events (AEs) will be recorded from the start of Study Treatment until the follow-up contact.

AEs will be recorded from the start of Study Treatment until the follow-up contact.

PK parameters include: maximum observed plasma concentration (Cmax), time to Cmax (tmax), area under the plasma concentration-time curve from time zero (pre-dose) to last time of quantifiable concentration (AUC [0-t]) and from time zero extrapolated to infinite time (AUC[0-infinity]), apparent terminal phase half-life (t1/2). AUC (0-infinity) or area under the concentration-time curve over the dosing interval (AUC[0-tau]) and Cmax following single and repeat doses may be used for assessment of dose proportionality.

PK parameters include: Cmax, tmax, (AUC [0-t]), (AUC [0-infinity]), (t1/2). AUC (0-infinity) or (AUC [0-tau]) and Cmax following single and repeat doses may be used for assessment of dose proportionality. Trough concentration (Ctau) samples collected on the specified days may be used to assess attainment of steady state.

Percent inhibition of soluble sEH enzyme activity in whole blood will be measured from plasma samples. GSK2256294 is a potent and reversible inhibitor of sEH and this will be evaluated to determine the PD effect of GSK2256294 on sEH enzyme activity.

The PD inhibitory effect of repeat oral doses of GSK2256294 on sEH inhibition in the study population will be investigated via the sEH enzyme inhibition assay and the ratio of leukotoxin to leukotoxin diol data subject to data available from the study. Samples will be collected to measure sEH enzyme inhibition and the ratio of substrate to product for biomarkers: leukotoxin: leukotoxin diol ratio

Based on the availability of data, a PK/PD model will be attempted to explain the dose response (exposure response) relationship between GSK2256294 and the various biomarkers analyzed in the study.

A plethysmograph is an instrument for measuring changes in volume within an organ or whole body (usually resulting from fluctuations in the amount of blood or air it contains). It will be used to determine the effects of GSK2256294 and placebo on endothelium-dependent and independent vasodilatation.

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

GlaxoSmithKline

Dronabinol 2.5 mg will be taken orally with water twice per day for two days.

Dronabinol 5 mg will be taken orally with water twice per day for two days.

Placebo will be taken orally with water twice per day for two days.

Dronabinol 2.5 mg Bid

Dronabinol 5 mg Bid

Total

Sex: Female, Male

Region of Enrollment

Body Mass Index (BMI)

The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.

Colonic Transit Geometric Center

The time for half of the ingested solids or liquids to leave the stomach.

Gastric Emptying Half-Time (t1/2)

Percent of the radio-labeled meal that reached the colon at 6 hours, indirectly reflecting small bowel transit time.

Colonic Filling at 6 Hours

Ascending colon emptying t1/2 will be estimated by power exponential analysis of the proportionate emptying over time of counts from the colon. The primary data for this analysis will be the proportion of decay and depth-corrected counts in the ascending colon on the hourly scans on the first day of transit measurement and the 48 hour data.

Ascending Colon Emptying T 1/2

Proportion of stomach contents emptied at a 2 and 4 hours.

Gastric Emptying at 2 and 4 Hours

Colonic Transit Geometric Center at 24 Hours

Overall Study

Dr. Michael Camilleri

Irritable Bowel Syndrome

Dronabinol is a synthetic delta-9-tetrahydrocannabinol, a nonselective cannabinoid agonist. Subjects will receive either 2.5 mg bid, or 5 mg bid, taken orally with water for 2 days.

Dronabinol

Placebo will match study drug; taken orally with water twice per day for two days.

hydrolase/таргалалт

Probiotics for Gallstones in Post-bariatric Surgery Patients：A Prospective Randomized Trial

A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Doses of GSK2256294 in Healthy Volunteers, and Single and Repeat Doses of GSK2256294 in Adult Male Moderately Obese Smokers

Effect of Cannabinoid Agonist on Gastrointestinal and Colonic Motor Functions in Patients With Irritable Bowel Syndrome (IBS)

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