Piperaquine Granule Formulation Relative Bioavailability and Food Effect Study in Healthy Volunteers.

Inclusion Criteria

Participants must fulfil all of the following criteria to be eligible for enrolment in this trial:

• Female or Male aged ≥18 years to ≤55 years at the date of signing informed consent.
• Ability to provide written, personally signed, and dated informed consent to participate in the trial, in accordance with the ICH Good Clinical Practice (GCP) and applicable regulations, before any trial-related procedures.
• An understanding, ability, and willingness to fully comply with trial procedures and restrictions.
• Female participants must agree to follow contraceptive requirements as indicated in Section 13.2.2, from at least 30 days prior to first dosage to 16 weeks after last dosage.
• Agrees not to donate sperm or ova from the time of the first administration of trial medication until twelve weeks after the end of the systemic exposure of the trial drug.
• Participants must have a body weight of 50 kg or greater and a BMI between 18.0 kg/m² - 30.0 kg/m² (inclusive) at screening.
• Satisfactory medical assessment with no clinically significant or relevant abnormalities as determined by; medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG) and clinical laboratory evaluation that is reasonably likely to interfere with the participant's participation in or ability to complete the trial as assessed by the Investigator.

Exclusion Criteria

Participants will be excluded from enrolment in this trial if they fulfil any of the criteria below:

• Prior screen failure or randomisation in this trial. NOTE: Participants who initially failed due to temporary non-medically significant issues are eligible for re-screening once the cause has resolved.
• Female participant who is pregnant (from history, examination or confirmed by a positive serum pregnancy test at screening and/or on Day -1) or breastfeeding.
• Male participants with a female partner(s) who is (are) pregnant or lactating at screening and/or on Day -1, or is (are) expected to be during the trial period.
• Has a mental incapacity or language barriers precluding adequate understanding, co-operation, or compliance with the trial requirements.
• Unable or unwilling to follow a standardised diet and meal schedule or unable to fast, as required during the trial.
• Has milk intolerance.
• Unable to swallow tablets.
• Has veins on either arm that are unsuitable for intravenous puncture or cannulation (e.g., veins that are difficult to locate, or a tendency to rupture during puncture).
• Known or suspected intolerance or hypersensitivity to the investigational products, any closely related compound, or any of the stated ingredients.
• History of significant allergic reaction (e.g., anaphylaxis, angioedema) to any product (food, pharmaceutical, etc) but excluding untreated, asymptomatic, seasonal allergies.
• Donated blood or blood products (excluding plasma) within 90 days prior to trial medication administration.
• Has received or plans to receive a COVID-19 vaccination within two weeks before to one week after trial last visit.
• Treated with medication containing PQP within 90 days or five half-lives preceding the dose of trial medication (whichever is the longer).
• Ingested herbal remedies or dietary supplements containing St. John's Wort in the 30 days before the planned Day 1 of the dosing Part.
• Taking medicinal products that are known to prolong the QTc interval (see http://www.crediblemeds.org/). An up-to-date list will be in the study specific manual.
• Use of any medication that is either a moderate or strong inhibitor or inducer of CYP3A4 within 30 days or five half-lives (whichever is longer) prior to the planned day of dosing (see Drug Development and Drug Interactions, Table of Substrates, Inhibitors and Inducers, FDA). Anup to date list will be in the study specific manual.
• Use of any other prescription medication (excluding hormonal contraception and hormone replacement therapy) withi