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Outcome Measures

Primary Outcomes (2)

Maximum observed plasma concentration (Cmax)
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
72 hours
Area under the plasma concentration-time curve from time 0 to 12 hours (AUC0-12)
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
12 hours

Secondary Outcomes (1)

Area under the plasma concentration-time curve from time 0 to 72 hours (AUC0-72)
72 hours

Study Arms (2)

Chenodeoxycholic acid capsules

EXPERIMENTAL

Chenodeoxycholic acid capsules (250mg chenodeoxycholic acid)

Drug: Chenodeoxycholic acid

Chenodeoxycholic acid leadiant hard capsules

ACTIVE COMPARATOR

Chenodeoxycholic acid leadiant hard capsules (250mg chenodeoxycholic acid)

Drug: Chenodeoxycholic acid leadiant

Interventions

Chenodeoxycholic acidDrug

Two capsules were administered orally

Chenodeoxycholic acid capsules

Chenodeoxycholic acid leadiantDrug

Two capsules were administered orally

Chenodeoxycholic acid leadiant hard capsules

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 50 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

The subject is Caucasian \& aged between eighteen to fifty years (18 - 50), both inclusive.
The subject is within the limits for his height \& weight as defined by the body mass index range (18.5 - 25.0 Kg/m2).

MeSH Terms

Conditions

Xanthomatosis, Cerebrotendinous

Interventions

Chenodeoxycholic Acid

Condition Hierarchy (Ancestors)

Lipid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesXanthomatosis

Intervention Hierarchy (Ancestors)

Deoxycholic AcidCholic Acids

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (1)

Study Arms (2)

Chenodeoxycholic acid capsules

Chenodeoxycholic acid leadiant hard capsules

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (1)

Study Arms (2)

Chenodeoxycholic acid capsules

Chenodeoxycholic acid leadiant hard capsules

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations