A Comparative Bioavailability Study of DFD-29 Capsules 40 mg Versus SOLODYN® Tablets 105 mg, Under Fasting & Fed Conditions in Healthy Adult Human Subjects
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      Single-center, randomized, open-label, laboratory-blinded, 3-treatment, 3-period, 6-sequence,
      single-dose, crossover study.
    

Detailed description: 
      Primary Objectives:

        -  To assess the comparative bioavailability of DFD-29 (Minocycline ER Capsules 40 mg)
           versus SOLODYN® (Minocycline ER Tablets 105 mg) following a single oral dose
           administration under fasting conditions in healthy adult human subjects.

        -  To assess the effect of food on DFD-29 (Minocycline ER Capsules 40 mg).

      Secondary Objective:

      - To evaluate and compare the safety and tolerability profiles of each study treatment.

      Study Treatments:

      Treatment-A: A single 40 mg dose of DFD-29 (Minocycline Hydrochloride) (1 × 40 mg
      Extended-Release capsule) administered following a 10-hour overnight fast Treatment-B: A
      single 40 mg dose of DFD-29 (Minocycline Hydrochloride) (1 × 40 mg Extended-Release capsule)
      administered following a 10-hour overnight fast and 30 minutes after the start of a high-fat,
      high calorie breakfast Treatment-C: A single 105 mg dose of SOLODYN® (Minocycline
      Hydrochloride) (1 × 105 mg Extended-Release tablet) administered following a 10-hour
      overnight fast.

      Number of Subjects: Twenty-four (24) subjects will be included in the study Duration of the
      Study: Up to 58 days (including Screening) - Single dose treatment in each period.

      PK Sample Collection: In each study period, 20 blood samples will be collected for PK
      assessments. The first blood sample will be collected prior to study treatment administration
      while the other blood samples will be collected at different timepoints up to 72 hours after
      study treatment administration.
    

Intervention name(s): DFD-29 (Minocycline) Fasting; DFD-29 (Minocycline) Fed; Solodyn (Minocycline) Fasting
Intervention type(s): Drug; Drug; Drug
Intervention description(s): In each study period, a single 40 mg dose of DFD-29 Capsules will be administered orally with approximately 240 mL of water, in the morning, following a 10-hour overnight fast.; In each study period, a single 40 mg dose of DFD-29 Capsules will be administered orally with approximately 240 mL of water, in the morning, following a 10-hour overnight fast and 30 minutes after the start of a high-fat, high-calorie breakfast.; In each study period, a single 105 mg dose of SOLODYN® Tablets will be administered orally with approximately 240 mL of water, in the morning, following a 10-hour overnight fast.
Other intervention name(s): Minocycline Hydrochloride; Minocycline Hydrochloride; Minocycline Hydrochloride
Intervention MeSH terms: Minocycline
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Single-center, randomized, open-label, laboratory-blinded, 3-treatment, 3-period, 6-sequence, single-dose, crossover study. Eligible subjects will be randomized to a treatment sequence as follows: ABC; BCA; CAB; ACB; BAC; CBA.
Masking: None (Open Label)
Primary purpose: Other