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drugset / Trial / NCT04866602

Atoguanil BA Study

NCT04866602 ↗

Phase 1 Completed 16 enrolled Medicines for Malaria Venture Richmond Pharmacology Limited · collab

RandomizedCrossoverOpen-labelBasic science

Summary

This trial aims to characterise the pharmacokinetic (PK) profile and estimate drug exposure from Atoguanil in comparison to Malarone®.

Timeline

Start: 2021-11-17
Primary completion: 2022-03-18
Completion: 2022-03-18

Publications

Kuemmerle A, Gossen D, Marx MW, Lorch U, Szramowska M, Kumar A, Singh D, Singh S, Ramachandruni H, Thankachen B, Kore S, Gaaloul ME, Borghini-Fuhrer I, Chalon S. A randomized, open-label two-period crossover pilot study to evaluate the relative bioavailability in the fed state of atovaquone-proguanil (Atoguanil) versus atovaquone-proguanil hydrochloride (Malarone(R)) in healthy adult participants. Naunyn Schmiedebergs Arch Pharmacol. 2024 Dec;397(12):9823-9832. doi: 10.1007/s00210-024-03245-x. Epub 2024 Jun 25.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Atovaquone	Small molecule	500 mg	Oral
Subject	Atovaquone	Small molecule	1000 mg	Oral
Subject	Proguanil	Small molecule	348 mg	Oral
Subject	Proguanil	Small molecule	400 mg	Oral

Indications

No indication recorded.