Bioequivalence Study to Compare Chenodeoxycholic Acid Capsules (250mg Chenodeoxycholic Acid) Vers… (NCT06180057) | Clinical Trial Compass
CompletedPhase 1
Bioequivalence Study to Compare Chenodeoxycholic Acid Capsules (250mg Chenodeoxycholic Acid) Versus Chenodeoxycholic Acid Leadiant 250 mg Hard Capsules (250mg Chenodeoxycholic Acid)
Jordan24 participantsStarted 2022-06-12
Plain-language 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.
Who can participate
Age range18 Years – 50 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 (0.1-20…
What they're measuring
1
Maximum observed plasma concentration (Cmax)
Timeframe: 72 hours
2
Area under the plasma concentration-time curve from time 0 to 12 hours (AUC0-12)