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

NCT06180057 | Completed Phase 1

• 1 other identifier: 1164-2022
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebrotendinous Xanthomatoses

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 acid DRUG

Two capsules were administered orally

Chenodeoxycholic acid capsules

Chenodeoxycholic acid leadiant DRUG

Two capsules were administered orally

Chenodeoxycholic acid leadiant hard capsules

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (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).
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Humanis Saglık Anonim Sirketi: lead

Study Sites (1)

ACDIMA Biocenter

Amman, Jordan

Location

MeSH Terms

Conditions

Xanthomatosis, Cerebrotendinous

Interventions

Chenodeoxycholic Acid

Condition Hierarchy (Ancestors)

Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Xanthomatosis

Intervention Hierarchy (Ancestors)

Deoxycholic Acid; Cholic Acids; Bile Acids and Salts; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholanes

Study Officials

• Hakan Gürpınar

  Humanis Saglık

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2023
• First Posted: December 22, 2023
• Study Start: June 12, 2022
• Primary Completion: July 18, 2022
• Study Completion: August 15, 2022
• Last Updated: December 28, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)