Clinical trials: Ursodeoxycholic Acid
Healthy
Ursodiol Tablets 500 mg Under Fasting Conditions
The objective of this study was to evaluate the comparative bioavailability between Ursodiol 500 mg Tablets (test) and Urso Forte™ 500 mg Tablets (reference) after a single-dose in healthy subjects under fasting conditions.
- Trial name
- NCT00909610
- Testing
- Ursodiol, Urso Forte™
- Where
- Canada
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Ursodiol 500 mg Tablets Under Fed Conditions
The objective of this study was to evaluate the comparative bioavailability between Ursodiol 500 mg Tablets (test) and Urso Forte™ 500 mg Tablets (reference)after a single-dose in healthy subjects under fed conditions.
- Trial name
- NCT00909753
- Testing
- Ursodiol, Urso Forte™
- Where
- Canada
- Volunteers
- 92 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Primary Biliary Cholangitis
A Study of Elafibranor in Adults With Primary Biliary Cholangitis and Inadequate Response or Intolerance to Ursodeoxycholic Acid.
The participants in this study will have confirmed PBC with inadequate response or intolerance to Ursodeoxycholic acid (UDCA), which is a medication used in the management and treatment of cholestatic liver disease.
- Trial name
- ELSPIRE (NCT06383403)
- Testing
- Elafibranor
- Where
- 60 sites in United States, Czechia and 8 more
- Volunteers
- 92 people
- Sponsor
- Ipsen
Cholelithiasis
Lithotripsy for the Treatment of Gallstones
The purpose of this study is to determine the effectiveness and safety of using the Medstone lithotripter to treat single non-calcified gallstones from 4 to 20 mm in diameter.
- Trial name
- NCT00042549
- Testing
- Extracorporeal Shock Wave Lithotripsy, ursodiol
- Where
- 2 sites in United States
- Volunteers
- 184 people, healthy volunteers welcome
- Sponsor
- Medstone International
Type 2 Diabetes Mellitus
A Phase 2 Study of Berberine Ursodeoxycholate (HTD1801) in Patients With Type 2 Diabetes Inadequately Controlled With Diet and Exercise
The goal of this clinical trial is to evaluate the efficacy and safety of berberine ursodeoxycholate (HTD1801) compared to placebo in patients with type 2 diabetes inadequately controlled with diet and exercise alone.
- Trial name
- NCT06411275
- Testing
- HTD1801
- Where
- 14 sites in China
- Volunteers
- 113 people
- Sponsor
- Shenzhen HighTide Biopharmaceutical Ltd.
Healthy
A Single-dose, Comparative Bioavailability Study of Two Formulations of Ursodiol 500mg Tablets Under Fed Conditions
single-dose, comparative bioavailability study of two formulations of ursodiol 500mg tablets under fed conditions
- Trial name
- NCT03512821
- Testing
- Ursodiol 500 MG, Urso Forte 500Mg Tablet
- Where
- Canada
- Volunteers
- 77 people, healthy volunteers welcome
- Sponsor
- Daewoong Pharmaceutical Co. LTD.
Healthy
A Multiple Dose Study of DWP10292 and UDCA in Healthy Male Subjects
The purpose of this study is to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of DWP10292 and UDCA in healthy male volunteers after multiple-dosing.
- Trial name
- NCT02622685
- Testing
- DWP10292, Ursodeoxycholic acid (UDCA)
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Daewoong Pharmaceutical Co. LTD.
Primary Biliary Cirrhosis
Study to Assess Safety & Efficacy of GKT137831 in Patients With Primary Biliary Cholangitis Receiving Ursodiol.
The purpose of this study is to assess the safety and efficacy of GKT13783 in patients with Primary Biliary Cholangitis (PBC) who are taking a stable dose of ursodeoxycholic acid (UDCA) treatment, and have persistently high…
- Trial name
- NCT03226067
- Testing
- GKT137831
- Where
- 61 sites in United States, Belgium and 7 more
- Volunteers
- 111 people
- Sponsor
- Calliditas Therapeutics AB
Primary Biliary Cholangitis
To Evaluate Safety and Tolerability of the Fixed- Dose Combination of Obeticholic Acid and Bezafibrate
An Open Label Long-Term Study to Evaluate the Safety and Tolerability of the Fixed-Dose Combination (FDC) of Obeticholic Acid (OCA) and Bezafibrate (BZF) tablet in Subjects with Primary Biliary Cholangitis (PBC).
- Trial name
- NCT06488911
- Testing
- FDC tablet (OCA 5 mg + BZF 400 mg SR)
- Where
- 51 sites in United States, Argentina and 19 more
- Volunteers
- 62 people
- Sponsor
- Intercept Pharmaceuticals
Primary Biliary Cirrhosis
Study of Elafibranor in Patients With Primary Biliary Cholangitis (PBC)
The participants of this study will have confirmed Primary Biliary Cholangitis (PBC) with inadequate response or intolerance to ursodeoxycholic acid (which is a medication used in the management and treatment of cholestatic liver…
- Trial name
- ELATIVE (NCT04526665)
- Testing
- Elafibranor 80mg
- Where
- 115 sites in United States, Argentina and 12 more
- Volunteers
- 161 people
- Sponsor
- Ipsen
Primary Biliary Cirrhosis
Primary Biliary Cirrhosis: Investigating A New Treatment Option Using NI-0801, an Anti-CXCL10 Monoclonal Antibody
The purpose of the study is to assess safety and efficacy of multiple doses of NI-0801 in primary biliary cirrhosis patients with an inadequate response to ursodeoxycholic acid.
- Trial name
- PIANO (NCT01430429)
- Testing
- NI-0801
- Where
- 2 sites in Italy, United Kingdom
- Sponsor
- Light Chain Bioscience - Novimmune SA
Primary Biliary Cholangitis
Study of Saroglitazar Magnesium for PBC Patients With Incomplete Response or Intolerant to UDCA Therapy
Study of Saroglitazar Magnesium for PBC Patients with Incomplete Response or Intolerant to UDCA Therapy
- Trial name
- EPICS-IV (NCT07424677)
- Testing
- Saroglitazar Magnesium 1 mg
- Where
- United States
- Volunteers
- 90 people
- Sponsor
- Zydus Therapeutics Inc.
Healthy
A Single-dose, Comparative Bioavailability Study of Two Formulations of Ursodiol 500mg Tablets Under Fasting Conditions
A single-dose, comparative bioavailability study of two formulations of ursodiol 500mg tablets under fasting conditions
- Trial name
- NCT03512808
- Testing
- Ursodiol 500 MG, Urso Forte 500Mg Tablet
- Where
- Canada
- Volunteers
- 77 people, healthy volunteers welcome
- Sponsor
- Daewoong Pharmaceutical Co. LTD.
Gastric Cancer
To Evaluate Efficacy of Ursodeoxycholic Acid (UDCA) for the Prevention of Gallstone Formation After Gasterectomy
Of those patients who participated in PEGASUS-D FAS clinical trial, patient must sign the informed consent form in order to participate in this extension study.
- Trial name
- NCT05410535
- Testing
- Patients who continued UDCA 300mg medication, Patients who discontinued UDCA 300mg prescription
- Where
- South Korea
- Volunteers
- 431 people
- Sponsor
- Daewoong Pharmaceutical Co. LTD.
Primary Biliary Cholangitis
Study to Evaluate the Efficacy and Safety of K-808 (Pemafibrate) in Participants With Primary Biliary Cholangitis (PBC) With Inadequate Response to Ursodeoxycholic Acid (UDCA) and/or Obeticholic Acid (OCA) Treatment.
Study to investigate the efficacy and safety of two doses of K-808 (pemafribate) in subjects with PBC.
- Trial name
- NCT06247735
- Testing
- K-808 (Dose A), K-808 (Dose B)
- Where
- 38 sites in United States, Canada and 1 more
- Volunteers
- 46 people
- Sponsor
- Kowa Research Institute, Inc.
T2DM (Type 2 Diabetes Mellitus)
Effects of Berberine Ursodeoxycholate (HTD1801) Versus Dapagliflozin in Patients With Type 2 Diabetes Inadequately Controlled With Metformin
The goal of this clinical study is to evaluate the efficacy and safety of berberine ursodeoxycholate (HTD1801) compared to dapagliflozin in patients with type 2 diabetes inadequately controlled with metformin alone.
- Trial name
- HARMONY (NCT06415773)
- Testing
- HTD1801, Dapagliflozin
- Where
- 53 sites in China
- Volunteers
- 367 people
- Sponsor
- Shenzhen HighTide Biopharmaceutical Ltd.
Type 2 Diabetes Mellitus
Efficacy and Safety of Berberine Ursodeoxycholate (HTD1801) in Patients With Type 2 Diabetes Inadequately Controlled With Metformin
The goal of this clinical study is to evaluate the efficacy and safety of berberine ursodeoxycholate (HTD1801) compared to placebo in patients with type 2 diabetes inadequately controlled with metformin.
- Trial name
- SYMPHONY-2 (NCT06353347)
- Testing
- HTD1801
- Where
- 64 sites in China
- Volunteers
- 551 people
- Sponsor
- Shenzhen HighTide Biopharmaceutical Ltd.
Primary Biliary Cirrhosis
Study of Obeticholic Acid（OCA） Combination With Ursodeoxycholic Acid (UDCA) in Patients With Primay Biliary Cirrhosis (PBC)
Obecholic acid is a modified bile acid and Farnesoid X receptor (FXR) agonist. FXR is a key regulator of bile acid synthesis and transport. Bile acids are used by the body to help with digestion.
- Trial name
- NCT04956328
- Testing
- Obeticholic Acid Tablets, UDCA
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
PBC
Obeticholic Acid Versus Placebo, in Combination with Ursodeoxycholic Acid in Patients with Primary Biliary Cirrhosis
This is a Phase III, randomized, double-blind, multicentre study assessing the efficacy and safety of obecholic acid and Ursodeoxycholic Acid(UDCA) compared with placebo and UDCA in treating of primary biliary cirrhosis (PBC) in…
- Trial name
- NCT06715319
- Testing
- OCA, UDCA
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Primary Biliary Cirrhosis
A Study of Efficacy and Safety of Ustekinumab in Patients With Primary Biliary Cirrhosis (PBC) Who Had an Inadequate Response to Ursodeoxycholic Acid
The purpose of this study is to evaluate the efficacy and safety of ustekinumab in patients with primary biliary cirrhosis who had an inadequate response to ursodeoxycholic acid.
- Trial name
- NCT01389973
- Testing
- ustekinumab 90 mg, ustekinumab 45 mg, ustekinumab 180 mg
- Where
- 10 sites in United States, Canada
- Volunteers
- 20 people
- Sponsor
- Janssen Research & Development, LLC