Last updated: 11/07/2018 14:41:24
An Evaluation of the Pharmacokinetics of a Single Oral Dose of BRL 49653C in Patients with Varying Degrees of Renal Insufficiency Compared to Volunteers with Normal Renal Function
Clinicaltrials.gov ID
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EudraCT ID
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EU CT Number
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Trial status
Study complete
Study complete
Trial overview
Official title: An Evaluation of the Pharmacokinetics of a Single Oral Dose of BRL 49653C in Patients with Varying Degrees of Renal Insufficiency Compared to Volunteers with Normal Renal Function
Trial description: An Evaluation of the Pharmacokinetics of a Single Oral Dose of BRL 49653C in Patients with Varying Degrees of Renal Insufficiency Compared to Volunteers with Normal Renal Function
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
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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:
Abstract: 3/18/1999. RMIS SmithKline Beecham; Clinical Pharmacol Unit, Philadelphia, Pennsylvania San Antonio, TX; USA
Chapelsky MC, Thompson K, Miller A, Sack M, Blum R, Jorkasky D, Freed MI. Rosiglitazone (RSG; Avandia) pharmacokinetics are unaffected by renal impairment. Clin Pharmacol Ther 1999; 65: 185. Presented at ASCPT 1999.
Chapelsky, M. C.; Thompson-Culkin, K.; Miller, A. K.; Sack, M.; Blum, R., and Freed, M. I. (GlaxoSmithKline, 709 Swedeland Road, P.O. Box 1539, King of Prussia, PA 19406-0939, USA.). Pharmacokinetics of rosiglitazone in patients with varying degrees of renal insufficiency. [eng]. Chapelsky, Martha C; Thompson-Culkin, Kathleen; Miller, Ann K; Sack, Marshall; Blum, Robert, and Freed, Martin I. J Clin Pharmacol. 2003 Mar; 43(3):252-9; ISSN
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
Rosiglitazone: a review of its use in the management of type 2 diabetes mellitus. Wagstaff, A. J. and Goa, K. L. Drugs 2002; 62(12):1805-37
Medical condition
Diabetes Mellitus
Product
rosiglitazone
Collaborators
Not applicable
Study date(s)
May 1997 to December 1997
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
1997-12-12
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
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