NCT06180057

Bioequivalence Study to Compare Chenodeoxycholic Acid Capsules (250mg Chenodeoxycholic Acid) Versus Chenodeoxycholic Acid Leadiant 250 mg Hard Capsules (250mg Chenodeoxycholic Acid)

Randomized, Two-way, Two-period, Single Oral Dose, Open-label, Crossover, Bioequivalence Study to Compare Chenodeoxycholic Acid Capsules (250mg Chenodeoxycholic Acid) [Dose: 1 x 02 Capsules] Versus Chenodeoxycholic Acid Leadiant 250 mg Hard Capsules (250mg Chenodeoxycholic Acid) [Dose: 1 x 02 Capsules] in Healthy Subjects Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Humanis Saglık Anonim Sirketi · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

Randomized, two-way, two-period, single oral dose, open-label, crossover, bioequivalence study to compare Chenodeoxycholic acid capsules (250mg chenodeoxycholic acid) \[dose: 1 x 02 capsules\] versus Chenodeoxycholic acid leadiant 250 mg hard capsules (250mg chenodeoxycholic acid) \[dose: 1 x 02 capsules\] in healthy subjects under fasting conditions.

Conditions

• Cerebrotendinous Xanthomatoses

Interventions

Type	Name	Description
DRUG	Chenodeoxycholic acid	Two capsules were administered orally
DRUG	Chenodeoxycholic acid leadiant	Two capsules were administered orally

Timeline

• Start date: 2022-06-12
• Primary completion: 2022-07-18
• Completion: 2022-08-15
• First posted: 2023-12-22
• Last updated: 2023-12-28

Locations

1 site across 1 country: Jordan