Relative Bioavailability of Colcrys™ 0.6 mg Tablets in Healthy Young and Elderly Volunteers Under Fasted Conditions
Completed
Mutual Pharmaceutical Company, Inc.
Phase 1
2009-10-01
The purpose of this study is to evaluate and compare the relative bioavailability of a single
dose of Colcrys™ (colchicine) 0.6 mg when administered to a group of young , healthy subjects
18-30 years of age compared to a group of older, generally healthy subjects 60 years of age
or older following an overnight fast.
Healthy and Renal Impairment Study of Colcrys (Colchicine, USP)
Completed
Takeda
Phase 4
2010-05-01
The primary objective of this study is to compare the pharmacokinetic profiles of colchicine
and its primary metabolites in plasma and urine following a single 0.6 mg oral dose of
colchicine in healthy adults with normal renal function, in patients with mild, moderate or
severe renal impairment, and in patients with end-stage renal disease on hemodialysis. An
additional objective of this study is to study the clearance of colchicine and its
metabolites by hemodialysis. Secondary objectives include evaluation of the safety and
tolerability of colchicine in the study population.
An Assessment of Chronic Synovial-Based Inflammation and Its Role With Serum Urate Levels.
Completed
Takeda Pharmaceuticals North America, Inc.
Phase 4
2010-05-01
The purpose of this study is to show that patients with gout suffer from chronic inflammation
of their joints, observable by MRI, even in the absence of symptomatic gouty attacks.
Secondary end-points of this study will include analyzing the effects of uric acid-lowering
therapy (specifically with the FDA approved medication Febuxostat) in a subgroup of patients,
checking for the presence of inflammatory markers to see if there is any correlation with the
proposed chronic inflammation, and evaluating for other characteristic findings of gout on
MRI.
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.
Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data.
The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free.
thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user.
Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
Alerts Available With Subscription
Alerts are available for users with active subscriptions.
