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NCT04374864: Trelagliptin

Dose Modification Requirement for Trelagliptin in Egyptian Population

Status unknown Phase 4 Last updated 5 May 2020
What this trial tests

Phase 4 trial testing Trelagliptin in Diabetes Mellitus in 6 participants. Status unknown.

Timeline
1 March 2020
Primary endpoint
1 June 2020
1 July 2020

Quick facts

Lead sponsorBritish University In Egypt
PhasePhase 4
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposehealth services research
Enrollment6
Start date1 March 2020
Primary completion1 June 2020
Estimated completion1 July 2020
Sites1 location across Egypt

Drugs / interventions tested

Conditions studied

Sponsor

British University In Egypt

Who can join

Adults 25 to 39, any sex, with Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The proposed study will consider the pharmacokinetic evaluation of Trelagliptin after administration to Egyptian volunteers and the results will be compared with the other reported ethnic populations. The FDA recognizes that standard methods of defining racial subgroups are necessary to compare results across pharmacokinetic studies, and to assess potential subgroup differences. The design of the study is open labeled, one treatment, one period, single dose pharmacokinetic study.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Investigation of Pharmacokinetic Parameters of Trelagliptin in Egyptian Volunteers Using Sensitive LC-MS/MS: A Comparative Study with a Japanese Population.
    Mowaka S, Ashoush N, Tadros MM, Ayoub BM. · · 2021 · cited 1× · PMID 34925935 · DOI 10.1155/2021/9664099

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Other trials of Trelagliptin

Trials testing the same drug.

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Currently open trials in the same condition.

Other British University In Egypt trials

Trials by the same sponsor.

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Data sources for this page

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