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

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.

Study Overview

• Status: Completed
• Conditions: Cerebrotendinous Xanthomatoses
• Intervention / Treatment: Drug: Chenodeoxycholic acid; Drug: Chenodeoxycholic acid leadiant

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Jordan
  • Amman, Jordan
    • ACDIMA Biocenter

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria

• 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).
• The subject is willing to undergo the necessary pre- & post- medical examinations set by this study.
• The results of medical history, vital signs, physical examination & conducted medical laboratory tests are normal as determined by the clinical investigator.
• The subject tested negative for Hepatitis B (HBsAg), Hepatitis C (HCVAb) and human immunodeficiency virus (HIVAb).
• There is no evidence of psychiatric disorder, antagonistic personality and poor motivation, emotional or intellectual problems likely to limit the validity of consent to participate in the study or limit the ability to comply with protocol requirements.
• The subject is able to understand and willing to sign the informed consent form.
• For female subjects: negative serum pregnancy test and the woman is using a reliable contraception method.
• The subject has normal cardiovascular system & ECG recording.
• The subject kidney and liver (aminotransferase & Alanine transaminase enzymes) functions tests are within normal range. (Creatinine is accepted if below the reference range after being evaluated by the CI as clinically not significant).
• The subject has normal Triglyceride (0.1-150 mg/dl), HDL (35-55 mg/dl), LDL (0.1-159 mg/dl) and Total Cholesterol levels (0.1-200 mg/dl) or clinical insignificant based on CI evaluation.

Exclusion Criteria

• The subject is a heavy smoker (more than 10 cigarettes per day).
• The subject has suffered an acute illness one week before dosing.
• The subject has a history of or concurrent abuse of alcohol.
• The subject has a history of or concurrent abuse of illicit drugs.
• The subject has a history of hypersensitivity and/or contraindications to the study drug; including its excipients and any related compounds.
• The subject has been hospitalized within three months before the study or during the study.
• The subject is on special diet (for example subject is vegetarian.)
• The subject has consumed caffeine or xanthine containing beverages or foodstuffs within two days before dosing and until 72 hours after dosing in both study periods.
• The subject has taken a prescription medication within two weeks or even an over the counter product (OTC) within one week before dosing in each study period and any time during the study, unless otherwise judged acceptable by the clinical investigator.
• The subject has taken grapefruit/orange containing beverages or foodstuffs within seven (7) days before first dosing and any time during the study.
• The subject has been participating in any clinical study (e.g. pharmacokinetics, bioavailability and bioequivalence studies) within the last 80 days prior to the present study.
• The subject has donated blood within 80 days before first dosing.
• The subject has a history or presence of cardiovascular, pulmonary, renal, hepatic, gastrointestinal, hematological, endocrinal, immunological, dermatological, neurological, musculoskeletal or psychiatric diseases.
• Subject has consumed medicines or foodstuff that may affect pharmacological or pharmacokinetic properties of chenodeoxycholic acid (for example: Antacids (aluminum containing), Bile acid sequestrants such as (cholestyramine or colestipol), Clofibrate, Coumarin-derivative anticoagulants, Estrogens & oral contraceptive) two weeks before dosing, during the study and two weeks after dosing.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Chenodeoxycholic acid capsules; Chenodeoxycholic acid capsules (250mg chenodeoxycholic acid)	Drug: Chenodeoxycholic acid; Two capsules were administered orally
Active Comparator: Chenodeoxycholic acid leadiant hard capsules; Chenodeoxycholic acid leadiant hard capsules (250mg chenodeoxycholic acid)	Drug: Chenodeoxycholic acid leadiant; Two capsules were administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the plasma concentration-time curve from time 0 to 72 hours (AUC0-72)	The descriptive statistics for AUC0-72	72 hours

Collaborators and Investigators

• Sponsor: Humanis Saglık Anonim Sirketi
• Investigators: Study Director: Hakan Gürpınar, Humanis Saglık

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2022
• Primary Completion (Actual): July 18, 2022
• Study Completion (Actual): August 15, 2022

Study Registration Dates

• First Submitted: December 5, 2023
• First Submitted That Met QC Criteria: December 21, 2023
• First Posted (Actual): December 22, 2023

Study Record Updates

• Last Update Posted (Actual): December 28, 2023
• Last Update Submitted That Met QC Criteria: December 22, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Genetic Diseases, Inborn; Metabolism, Inborn Errors; Lipid Metabolism Disorders; Lipid Metabolism, Inborn Errors; Xanthomatosis, Cerebrotendinous; Xanthomatosis; Gastrointestinal Agents; Cathartics; Chenodeoxycholic Acid
• Other Study ID Numbers: 1164-2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No