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    Minocycline Hydrochloride Extended Release Tablet Met the FDA Requirement for Bioequivalent Study

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    Minocycline Hydrochloride Extended Release Tablet Met the FDA Requirement for Bioequivalent Study
    * : * : admin * : 2020-03-09 * : 0

    From the beginning of 2019, MHDC launched cGMP scale-up production of Minocycline Hydrochloride Extended Release Tablet (45mg, 55mg, 80 mg, and 115mg) and the bioequivalent study in order submit the ANDA application to FDA.

    After nearly a year of effort, the bioequivalent study of Minocycline Hydrochloride Extended Release Tablet, conducted in Syneos Health Co., a Canadian clinical trial company, has been recently completed.

    Experimental data show that the bioequivalent consistency of minocycline hydrochloride Extended Release Tablet (115mg) developed by MHDC compare with the reference product SOLODYN (115 mg) produced by MEDICIS PHARMACEUTICAL CORP., is in accordance with FDA requirements.

    The product of Minocycline Hydrochloride Extended Release Tablet one-time formally passed through the bioequivalent clinical trial, showing that the MHDC's research and development technology and level into the international advanced and top level.

    The specific data for bioequivalent study are as follows:

    For study 180249 fasting, the bioequivalence criteria are met: for this FDA study, the 90% confidence intervals must be within 80.00% to 125.00% meaning that the values presented below must be within 80.00% to 125.00% for the AUC0-t, AUC0-inf, and Cmax.

    The Summary of PK results for study (Project 180249)

    PK Parameter

    90% Lower CI (%)

    90% Upper CI (%)

    Ln(AUC0-t)

    98.28

    116.28

    Ln(AUC0-inf)

    98.80

    112.64

    Ln(Cmax)

    97.48

    110.08

    For study 180250 fed, the bioequivalence criteria are met: for this FDA study, the 90% confidence intervals must be within 80.00% to 125.00% meaning that the values presented below must be within 80.00% to 125.00% for the AUC0-t, AUC0-inf, and Cmax.

    Based on the results, the bioequivalence was concluded as evidenced by the lower and upper CI obtained when the Test Minocycline Hydrochloride is administered compared to the Reference Solodyn.

    The Summary of PK results for study (Project 180250).

    PK Parameter

    90% Lower CI (%)

    90% Upper CI (%)

    Ln(AUC0-t)

    98.50

    105.00

    Ln(AUC0-inf)

    98.79

    105.20

    Ln(Cmax)

    91.15

    103.49