Single Dose Oral Bioequivalence Study of Bempedoic Acid 180 mg Film Coated Tablet and Nilemdo® (B… (NCT06923956) | Clinical Trial Compass
CompletedPhase 1
Single Dose Oral Bioequivalence Study of Bempedoic Acid 180 mg Film Coated Tablet and Nilemdo® (Bempedoic Acid) 180 mg Film-coated Tablets in Healthy Adult Human Subjects Under Fasting Conditions.
India14 participantsStarted 2024-12-04
Plain-language summary
Single dose oral bioequivalence study of Bempedoic Acid 180 mg Film Coated Tablet and Nilemdo® (Bempedoic Acid) 180 mg Film-coated tablets in healthy adult human subjects under fasting conditions.
Who can participate
Age range18 Years – 55 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:
* Age: 18 to 55 years old, both inclusive.
* Gender: Male and/or non-pregnant, non-lactating female.
* Female of child-bearing potential must have a negative serum beta human chorionic gonadotropin (β-HCG) pregnancy test performed within 28 days prior to first dosing day. They must be using an acceptable form of contraception.
For female of child-bearing potential, acceptable forms of contraception include the following:
* Non hormonal intrauterine device in place for at least 3 months prior to the start of the study and remaining in place during the study period, or
* Barrier methods containing or used in conjunction with a spermicidal agent, or
* Surgical sterilization or
* Practicing sexual abstinence throughout the course of the study.
* Female will not be considered of child-bearing potential if one of the following is reported and documented on the medical history:
* Postmenopausal with spontaneous amenorrhea for at least one year, or
* Spontaneous amenorrhea for more than 6 months and less than one year with Serum Follicular Stimulating Hormone (FSH) level \> 40 mIU/mL, or
* Bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or
* Total hysterectomy and an absence of bleeding for at least 3 months.
* BMI: 18.5 to 30.0 kg/m2, both inclusive; BMI value should be rounded off to one significant digit after decimal point (e.g. 30.04 rounds down to 30.0, while 18.45 rounds up to 18.5).
* Non-smokers a…
What they're measuring
1
Maximum measured plasma concentration over the time span specified (Cmax)
Timeframe: 72.00 hours
2
The area under the plasma concentration versus time curve was calculated using the linear trapezoidal linear interpolation rule from the zero time point to the last quantifiable concentration (AUCt)