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

EARLY_PHASE1CompletedINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

September 13, 2022

Primary Completion Date

December 15, 2022

Study Completion Date

December 15, 2022

Conditions
Bioequivalence
Interventions
DRUG

Treatment A (investigational drug) followed by Treatment B (reference drug)

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.

DRUG

Treatment B (reference drug) followed by Treatment A (investigational drug)

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.

Trial Locations (1)

1011

University Hospital CHUV, Service of Clinical Pharmacology, Lausanne

All Listed Sponsors
collaborator

Permamed AG, Switzerland

UNKNOWN

collaborator

Galvita AG, Switzerland

UNKNOWN

lead

University Children's Hospital Basel

OTHER