NCT06557603

Bioequivalence Study of Ivermectin 1% Cream and Soolantra (Ivermectin) 10 mg/g Cream

Single Dose Bioequivalence Study of Ivermectin 1% Cream and Soolantra (Ivermectin) 10 mg/g Cream in Healthy Adult Human Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Humanis Saglık Anonim Sirketi · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Single dose bioequivalence study of Ivermectin 1% cream and Soolantra (Ivermectin) 10 mg/g cream in healthy adult human subjects.

Detailed description

An open label, randomized, four-period, two treatment, two-sequence, fully replicate, crossover, balanced, single dose bioequivalence study.

Conditions

• Rosacea

Interventions

Type	Name	Description
DRUG	Ivermectin cream	\[1 gm ± 0.030 gm\] of product was applied in a thin layer over the entire face (avoiding the eyes, lips, and mucous membranes).
DRUG	Soolantra ® (Ivermectin) cream	\[1 gm ± 0.030 gm\] of product was applied in a thin layer over the entire face (avoiding the eyes, lips, and mucous membranes).

Timeline

• Start date: 2024-03-06
• Primary completion: 2024-07-11
• Completion: 2024-07-22
• First posted: 2024-08-16
• Last updated: 2024-08-20

Locations

1 site across 1 country: India