Trials Sponsors Conditions Drugs Pricing

Conditions

Healthy

Keywords

ECGPharmacokinetic profile

Outcome Measures

Primary Outcomes (2)

Changes of QTc within 24 hours after dosing
24 hours after dosing
Area under the curve
Area under the curve within 24 hours after dosing
24 hours after dosing

Secondary Outcomes (1)

Number of participant with adverse event
24 hours after dosing

Study Arms (2)

Chloroquine

ACTIVE COMPARATOR

Chloroquine base 600 mg single dose

Drug: Dihydroartemisinin-piperaquine

Dihydroartemisinin-piperaquine

ACTIVE COMPARATOR

Dihydroartemisinin-piperaquine 120/960 mg single dose

Drug: Chloroquine

Interventions

ChloroquineDrug

Chloroquine base 600 mg single dose. To monitor ECG 12 lead at 0 (pre-dose), 1, 2, 4, 8, 12 and 24 hours after dosing.

Dihydroartemisinin-piperaquine

Dihydroartemisinin-piperaquineDrug

Dihydroartemisinin-piperaquine 120/960 mg single dose To monitor ECG 12 lead at: 0 (pre-dose), 1, 2, 4, 8, 12 and 24 hours after dosing.

Chloroquine

Eligibility Criteria

Age18 Years - 60 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Healthy as judged by a responsible physician with no abnormality identified on a medical evaluation including medical history and physical examination
Male and female subjects aged between 18 years to 60 years.

Sponsors & Collaborators

University of Oxford
Otherlead

Study Sites (1)

Faculty of Tropical Medicine, Mahidol University

Bangkok, 10400, Thailand

MeSH Terms

Interventions

Chloroquine

Intervention Hierarchy (Ancestors)

AminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

Borimas Hanboonkunupakarn, MD
Faculty of Tropical Medicine, Mahidol University, Thailand
PRINCIPAL INVESTIGATOR

Enrollment

16 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 4
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: HEALTH SERVICES RESEARCH
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

July 1, 2014

First Posted

July 17, 2014

Study Start

July 2014

Date type not reported

This date has not been verified as actual or estimated.

You may not qualify if:

Females who are pregnant, trying to get pregnant, or are lactating.
The subject has evidence of active substance abuse that may compromise safety, pharmacokinetics, or ability to adhere with protocol instructions.
A positive pre-study hepatitis B surface antigen, positive hepatitis C antibody, or positive human immunodeficiency virus-1 (HIV-1) antibody result at screening.
Subjects with a personal history of hypertension, cardiac disease, symptomatic or asymptomatic arrhythmias, syncopal episodes, or additional risk factors for torsades de points (heart failure, hypokalemia).
Subjects with a family history of sudden cardiac death.
A creatinine clearance \<70 mL/min as determined by Cockcroft-Gault equation:
CLcr (mL/min) = (140 - age) \* Wt / (72 \* Scr) (multiply answer by 0.85 for females) Where age is in years, weight (wt) is in kg, and serum creatinine (Scr) is in units of mg/dL \[Cockcroft, 1976\].
History of alcohol or substance abuse or dependence within 6 months of the study: History of regular alcohol consumption averaging \>7 drinks/wk for women or \>14 drinks/wk for men. One drink is equivalent to 12 g alcohol = 5 oz (150 mL) of wine or 12 oz (360 mL) of beer or 1.5 oz (45 mL) of 80 proof distilled spirits within 6 months of screening.
Use of prescription or non-prescription drugs except paracetamol at doses of up to 2 grams/day, including vitamins, herbal and dietary supplements (including St. John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication until the completion of the follow-up procedure, unless in the opinion of investigator, the medication will not interfere with the study procedures or compromise subject safety.
The subject has participated in a clinical trial and has received a drug or a new chemical entity within 30 days or 5 half lives, or twice the duration of the biological effect of any drug (whichever is longer) prior to the first dose of study medication.
The subject is unwilling to abstain from ingesting alcohol within 48 hours prior to the first dose of study medication until collection of the final pharmacokinetic sample.
Subjects who have donated blood to the extent that participation in the study would result in more than 300 mL blood donated within a 30-day period. Note: This does not include plasma donation.
Subjects who have a history of allergy to the study drug or drugs of this class, or a history of drug or other allergy that, in the opinion of the investigator, contraindicates participation in the trial. In addition, if heparin is used during pharmacokinetic sampling, subjects with a history of sensitivity to heparin or heparin-induced thrombocytopenia should not be enrolled.
Those who, in the opinion of the investigator, have a risk of non-compliance with study procedures.
AST or ALT \>1.5 upper limit of normal (ULN).
+4 more criteria

Comparison of the ECG Effects Related to Pharmacokinetic Profile of Chloroquine and Piperaquine

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (1)

Study Arms (2)

Chloroquine

Dihydroartemisinin-piperaquine

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (1)

Study Arms (2)

Chloroquine

Dihydroartemisinin-piperaquine

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations