Atoguanil BA Study

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

Outcome

Mixed primary results

paper Frel was assumed similar if 90%CIs were between 80 and 125% PMID 38918235 ↗

paper Frel was similar for ATV Cmax (93.6% [90%CI 83.6, 104.9]) but not AUC0-inf (77.8% [67.4, 89.8]) PMID 38918235 ↗

paper for PG AUC0-inf (95.6% [92.1, 99.2]) but not Cmax (82.4% [75.8, 89.5]) PMID 38918235 ↗

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.