Ursofalk® 500 mg film-coated tablets ( DrugBank: - )


1 disease
IDDisease name (Link within this page)Number of trials
93Primary biliary cholangitis2

93. Primary biliary cholangitis


Clinical trials : 282 Drugs : 245 - (DrugBank : 56) / Drug target genes : 35 - Drug target pathways : 113
No.TrialIDDate_
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PhaseCountries
1EUCTR2008-001524-31-NL
(EUCTR)
26/11/200817/07/2008Double-blind, double-dummy, randomized, crossover, multicentre phase IV clinical study comparing the effect of Ursofalk® 500 mg tablets od versus Ursofalk® 250 mg capsules od on liver enzyme parameters in the treatment of primary biliary cirrhosis - Ursofalk® tablets versus Ursofalk® capsules in the treatment of PBCDouble-blind, double-dummy, randomized, crossover, multicentre phase IV clinical study comparing the effect of Ursofalk® 500 mg tablets od versus Ursofalk® 250 mg capsules od on liver enzyme parameters in the treatment of primary biliary cirrhosis - Ursofalk® tablets versus Ursofalk® capsules in the treatment of PBC Treatment of primary biliary cirrhosis
MedDRA version: 9.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis
Trade Name: Ursofalk® capsules
INN or Proposed INN: URSODEOXYCHOLIC ACID
Trade Name: Ursofalk® 500 mg film-coated tablets
INN or Proposed INN: URSODEOXYCHOLIC ACID
Dr. Falk Pharma GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
74Phase 4Germany;Netherlands
2EUCTR2008-001524-31-DE
(EUCTR)
26/08/200811/07/2008Double-blind, double-dummy, randomized, crossover, multicentre phase IV clinical study comparing the effect of Ursofalk® 500 mg tablets od versus Ursofalk® 250 mg capsules od on liver enzyme parameters in the treatment of primary biliary cirrhosis - Ursofalk® tablets versus Ursofalk® capsules in the treatment of PBCDouble-blind, double-dummy, randomized, crossover, multicentre phase IV clinical study comparing the effect of Ursofalk® 500 mg tablets od versus Ursofalk® 250 mg capsules od on liver enzyme parameters in the treatment of primary biliary cirrhosis - Ursofalk® tablets versus Ursofalk® capsules in the treatment of PBC Treatment of primary biliary cirrhosis
MedDRA version: 9.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis
Trade Name: Ursofalk® capsules
INN or Proposed INN: URSODEOXYCHOLIC ACID
Trade Name: Ursofalk® 500 mg film-coated tablets
INN or Proposed INN: URSODEOXYCHOLIC ACID
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
74Phase 4Germany;Netherlands