Last updated: 11/07/2018 14:37:49
An Evaluation of the Pharmacokinetics of a Single Oral Dose of BRL 49653C in Hemodialysis-Dependent Patients with End Stage Renal Disease Compared to Volunteers with Normal Renal Function
Clinicaltrials.gov ID
Not applicable
EudraCT ID
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EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: An Evaluation of the Pharmacokinetics of a Single Oral Dose of BRL 49653C in Hemodialysis-Dependent Patients with End Stage Renal Disease Compared to Volunteers with Normal Renal Function
Trial description: An Evaluation of the Pharmacokinetics of a Single Oral Dose of BRL 49653C in Hemodialysis-Dependent Patients with End Stage Renal Disease Compared to Volunteers with Normal Renal Function
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Pharmacokinetics of rosiglitazone in patients with end-stage renal disease. Thompson-Culkin, K., Zussman, B., Miller, A. K., and Freed, M. I. J Int Med Res 2002; 30(4):391-9
Pharmacokinetics of rosiglitazone in patients with varying degrees of renal insufficiency. Chapelsky, M. C., Thompson-Culkin, K., Miller, A. K., Sack, M., Blum, R., and Freed, M. I. J Clin Pharmacol 2003; 43(3):252-9
Thompson K, Zussman B, Miller A, Jorkasky D, Freed M. Pharmacokinetics of rosiglitazone are unaltered in hemodialysis patients. Clin Pharmacol Ther 1999; 65: 186. P111-40 presented at ASCPT 1999.
Thompson-Culkin K, Zussman B, Miller AK, Freed MI. Pharmacokinetics of rosiglitazone in patients with end-stage renal disease. J Int Med Res 2002; 30:391-399.
Medical condition
Diabetes Mellitus
Product
rosiglitazone
Collaborators
Not applicable
Study date(s)
April 1997 to January 1998
Type
Not applicable
Phase
1
Participation criteria
Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable
Inclusion and exclusion criteria
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Not applicable
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
1998-26-01
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Not applicable
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