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

Phase 1

Completed

• Conditions: Cerebrotendinous Xanthomatoses
• Interventions: Drug: Chenodeoxycholic acid leadiant; Drug: Chenodeoxycholic acid

• Registration Number: NCT06180057
• Lead Sponsor: Humanis Saglık Anonim Sirketi

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-12
• Primary Completion: 2022-07-18
• Study Completion: 2022-08-15
• Status Verified: 2023-12
• Study First Submitted: 2023-12-05
• Study First Submitted QC: 2023-12-21
• Study First Posted: 2023-12-22
• Last Update Submitted: 2023-12-22
• Last Update Posted: 2023-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Chenodeoxycholic acid leadiant hard capsules	Chenodeoxycholic acid leadiant	Chenodeoxycholic acid leadiant hard capsules (250mg chenodeoxycholic acid)
Chenodeoxycholic acid capsules	Chenodeoxycholic acid	Chenodeoxycholic acid capsules (250mg chenodeoxycholic acid)

Primary Outcome Measures

Name	Time	Method
Maximum observed plasma concentration (Cmax)	72 hours	Statistical analysis of primary endpoints will include descriptive statistics, Analysis of Variance (ANOVA), and Confidence Interval (CI). The average bioequivalence of the products is concluded if the two-sided 90 % CI for the test to reference ratio of the population means is within 80.00 - 125.00 % for each of the Ln-transformed data for Cmax
Area under the plasma concentration-time curve from time 0 to 12 hours (AUC0-12)	12 hours	Statistical analysis of primary endpoints will include descriptive statistics, Analysis of Variance (ANOVA), and Confidence Interval (CI). The average bioequivalence of the products is concluded if the two-sided 90 % CI for the test to reference ratio of the population means is within 80.00 - 125.00 % for each of the Ln-transformed data for AUC0-12

Secondary Outcome Measures

Name	Time	Method
Area under the plasma concentration-time curve from time 0 to 72 hours (AUC0-72)	72 hours	The descriptive statistics for AUC0-72

Trial Locations

Locations (1)

ACDIMA Biocenter; 🇯🇴 Amman, Jordan