A Randomized, Single-Dose, Three-Way Crossover Comparative Bioavailability Study of DFD-29 (Minocycline Hydrochloride ER Capsules 40 mg) Versus SOLODYN® (Minocycline Hydrochloride ER Tablets 105 mg), Under Fasting and Fed Conditions in Healthy Adult Human Subjects
Overview
- Phase
- Phase 1
- Intervention
- DFD-29 (Minocycline) Fasting
- Conditions
- Pharmacokinetics
- Sponsor
- Journey Medical Corporation
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Peak Plasma Concentration (Cmax) of DFD-29 compared to Solodyn(R)
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Provision of signed and dated Informed Consent Form (ICF)
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Healthy adult male or postmenopausal females
- •If female, meets one of the following criteria:
- •Physiological postmenopausal status, defined as the following:
- •Absence of menses for at least 1 year prior to the first study treatment administration (without an alternative medical condition); and
- •Follicle stimulating hormone (FSH) levels ≥ 40 mIU/mL at Screening; Or
- •Surgical postmenopausal status, defined as the following:
- •Bilateral oophorectomy; and
- •Absence of menses for at least 90 days prior to the first study treatment administration; and
Exclusion Criteria
- •Female who is lactating
- •Female who is pregnant according to the pregnancy test at Screening
- •History of significant hypersensitivity or idiosyncratic reaction to minocycline or any of the tetracyclines (eg. severe skin reactions, erythema multiforme and/or drug reaction with eosinophilia and systemic symptoms) or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs
- •Presence or history of significant gastrointestinal, liver or kidney disease, or any other condition that is known to interfere with drug absorption, distribution, metabolism or excretion, or known to potentiate or predispose to undesired effects
- •History of or current complaints of orthostatic hypotension, auto-immune disease or photosensitivity reactions to drugs.
- •History or current complaints suggestive of raised intracranial pressure or vestibular disorders (e.g., light headedness, vertigo, and tinnitus).
- •History of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic, or dermatologic disease
- •Subject has liver enzymes i.e., alanine aminotransferase (ALT) and aspartate transaminase (AST) \> 1.5 x × upper limit of normal, at Screening.
- •Estimated glomerular filtration rate (eGFR) ≤ 60 mL/min/1.73 m2 at Screening
- •Presence of out-of-range cardiac interval (PR \< 110 msec, PR \> 200 msec, QRS \< 60 msec, QRS \>110 msec and QTcF \> 440 msec) on the ECG at Screening or other clinically significant ECG abnormalities, unless deemed non-significant by an Investigator
Arms & Interventions
DFD-29 under fasting condition
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.
Intervention: DFD-29 (Minocycline) Fasting
DFD-29 after high-fat meal
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.
Intervention: DFD-29 (Minocycline) Fed
Solodyn under fasting condition
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
Intervention: Solodyn (Minocycline) Fasting
Outcomes
Primary Outcomes
Peak Plasma Concentration (Cmax) of DFD-29 compared to Solodyn(R)
Time Frame: Time '0' to '72' hours after a single dose treatment
Peak plasma concentration (Cmax) - the 90% CI for the ratio of Geometric Least Square Means for the ln-transformed parameter Cmax will be compared between the three treatments.
Area under the Curve (AUC0-inf) of DFD-29 compared to Solodyn(R)
Time Frame: Time '0' to '72' hours after a single dose treatment
Area under the Curve (AUC0-inf) - the 90% CI for the ratio of Geometric Least Square Means for the ln-transformed parameter AUC0-inf will be compared between the three treatments.
Secondary Outcomes
- Number of participants with treatment-related adverse events (AE)(Before and up to 14 days after the last dose study treatment)