Bioequivalence of a Single-dose of 12 mg IVERMECTIN as Orally Disintegrating Mini Tablets Versus a Single-dose of 12 mg Regular IVERMECTIN Tablets in Healthy Adults Under Fasting Conditions
Condition: Bioequivalence
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This is a phase I, single-center, open-label, randomized, two-period, two-way crossover,
      single-dose bioequivalence study in which the active substance ivermectin is administered as
      a single dose of 12 mg as either CHILD-IVITAB or STROMECTOL during two study drug
      administration periods. Each treatment will be investigated in the same subgroup of 16
      healthy male or female study participants under fasted conditions.
    

Detailed description: 
      Ivermectin is used in humans as an oral antiparasitic agent. Currently approved ivermectin
      tablets are designed for adult patients. A child-appropriate formulation is not yet
      available. Ivermectin in suspension is not practicable as the stability is fragile, the
      shelf-life is very short, and the suspension is affected by UV light exposure. If tablets are
      offered to infants and young children as crushed or in a suspended form they are prone to
      imprecise dosing (loss of product after crushing or sedimentation of product after
      suspension). They are not palatable, and thereby frequently expelled out of the mouth by the
      child. All above compromise drug-adherence and effectiveness of treatment. In this
      bioequivalence study in healthy adults, CHILD-IVITAB, a novel orally disintegrating tablet
      (ODT) formulation containing the active ingredient ivermectin, will be evaluated.
      CHILD-IVITABs are stable in hot and humid atmosphere and no external agent is required for
      taste masking or swallowing. This study aims to determine if 12 mg of CHILD-IVITAB
      administered in a single dose is bioequivalent (with 0.80, 1.25 as the bioequivalence
      boundaries for AUC0-∞) to 12 mg administered as a single dose of the reference formulation
      STROMECTOL under fasting conditions. Further this study aims to characterize tolerability of
      CHILD-IVITAB in healthy adults.
    

Intervention name(s): Treatment A (investigational drug) followed by Treatment B (reference drug); Treatment B (reference drug) followed by Treatment A (investigational drug)
Intervention type(s): Drug; Drug
Intervention description(s): Two drug administration periods (1 and 2), each consisting of administration of Treatment A (investigational drug) followed by Treatment B (reference drug) on Day 1 will be performed. Post administration of the study drug standard PK sampling, measurement of vital signs, adverse events, ECG and VAS as per schedule will be done over a time period of 11 hours. The study participants will thereafter be discharged. The participants will return to the study center at 24, 48, 72 and 96 hours after study drug administration in each treatment period for blood sampling, vital signs and safety assessments as per schedule. The wash-out period between doses will be at least 7 days.; Two drug administration periods (1 and 2), each consisting of administration of Treatment B (reference drug) followed by Treatment A (investigational drug) or on Day 1 will be performed. Post administration of the study drug standard PK sampling, measurement of vital signs, adverse events, ECG and VAS as per schedule will be done over a time period of 11 hours. The study participants will thereafter be discharged. The participants will return to the study center at 24, 48, 72 and 96 hours after study drug administration in each treatment period for blood sampling, vital signs and safety assessments as per schedule. The wash-out period between doses will be at least 7 days.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: open-label, randomized, two-period, two-way crossover, single-dose bioequivalence study
Masking: None (Open Label)
Primary purpose: Other
Keywords: CHILD-IVITAB; STROMECTOL; Ivermectin; Palatability