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)

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)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Insud Pharma · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Evaluation of the bioavailability and safety of one oral preparation containing fixed dose 18 mg ivermectin (IVM 18 MG TABLETS, LICONSA S.A., Spain) or two oral preparations containing fixed dose 18 mg ivermectin (IVM 36 MG TABLETS, LICONSA S.A., Spain) vs. reference dosing (weight based) of reference drug containing 6 mg ivermectin (REVECTINA®, Abbott Laboratórios do Brasil Ltda, Brazil) in fasting conditions. A monocentric, open, randomized, single dose, three-period crossover trial in healthy volunteers.

Conditions

• Helminthiasis

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2016-03-01
• Primary completion: 2016-12-01
• Completion: 2017-01-01
• First posted: 2017-06-02
• Last updated: 2017-06-02