# Pharmacokinetics, Safety, Tolerability and Efficacy of a New Artemether-lumefantrine Dispersible Tablet in Infants and Neonates <5 kg Body Weight With Acute Uncomplicated Plasmodium Falciparum Malaria

> **NCT04300309** · PHASE2,PHASE3 · TERMINATED · sponsor: **Novartis Pharmaceuticals** · enrollment: 28 (actual)

## Conditions studied

- Plasmodium Falciparum Malaria

## Interventions

- **DRUG:** artemether:lumefantrine (2.5 mg:30 mg)

## Key facts

- **NCT ID:** NCT04300309
- **Lead sponsor:** Novartis Pharmaceuticals
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE2,PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2020-12-21
- **Primary completion:** 2023-07-02
- **Final completion:** 2024-05-10
- **Target enrollment:** 28 (ACTUAL)
- **Why stopped:** Sponsor decision
- **Last updated:** 2026-01-13

## Collaborators

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## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04300309

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04300309, "Pharmacokinetics, Safety, Tolerability and Efficacy of a New Artemether-lumefantrine Dispersible Tablet in Infants and Neonates <5 kg Body Weight With Acute Uncomplicated Plasmodium Falciparum Malaria". Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/clinical/NCT04300309. Licensed CC0.

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