NCT03173742 - Bioavailability and Safety of Two Oral Fixed Dose Preparations Containing 18 mg Ivermectin (IVM 18 MG TABLETS, LICONSA S.A., Spain) Versus Reference Dosing (Weight Based) Containing 6 mg Ivermectin (REVECTINA®, Abbott Laboratórios do Brasil Ltda, Brazil) | Biotech Hunter

Enrollment

54

Participants

Timeline

Start Date

March 31, 2016

Primary Completion Date

December 31, 2016

Study Completion Date

January 31, 2017

Conditions

Helminthiasis

Interventions

DRUG

T1, T2, T3

"T1: Ivermectin 6 mg (Revectina®) administered according to the SmPC by body weight.~T2: Ivermectin 18 mg (IVM 18 mg Tablet Liconsa x 1 tablet) T3: Ivermectin 36 mg (IVM 18 mg Tablet Liconsa x 2 tablets)"

DRUG

T1,T3,T2

"T1: Ivermectin 6 mg (Revectina®) administered according to the SmPC by body weight.~T2: Ivermectin 18 mg (IVM 18 mg Tablet Liconsa x 1 tablet) T3: Ivermectin 36 mg (IVM 18 mg Tablet Liconsa x 2 tablets)"

DRUG

T2,T1,T3

"T1: Ivermectin 6 mg (Revectina®) administered according to the SmPC by body weight.~T2: Ivermectin 18 mg (IVM 18 mg Tablet Liconsa x 1 tablet) T3: Ivermectin 36 mg (IVM 18 mg Tablet Liconsa x 2 tablets)"

DRUG

T2,T3,T1

"T1: Ivermectin 6 mg (Revectina®) administered according to the SmPC by body weight.~T2: Ivermectin 18 mg (IVM 18 mg Tablet Liconsa x 1 tablet) T3: Ivermectin 36 mg (IVM 18 mg Tablet Liconsa x 2 tablets)"

DRUG

T3,T1,T2

"T1: Ivermectin 6 mg (Revectina®) administered according to the SmPC by body weight.~T2: Ivermectin 18 mg (IVM 18 mg Tablet Liconsa x 1 tablet) T3: Ivermectin 36 mg (IVM 18 mg Tablet Liconsa x 2 tablets)"

DRUG

T3,T2,T1

"T1: Ivermectin 6 mg (Revectina®) administered according to the SmPC by body weight.~T2: Ivermectin 18 mg (IVM 18 mg Tablet Liconsa x 1 tablet) T3: Ivermectin 36 mg (IVM 18 mg Tablet Liconsa x 2 tablets)"