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| Name | Class |
|---|---|
| Dr. Reddy's Laboratories Limited | INDUSTRY |
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Single-center, randomized, open-label, laboratory-blinded, 3-treatment, 3-period, 6-sequence, single-dose, crossover study.
Primary Objectives:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DFD-29 under fasting condition | Experimental | 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. |
|
| DFD-29 after high-fat meal | Experimental | 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. |
|
| Solodyn under fasting condition | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DFD-29 (Minocycline) Fasting | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) of DFD-29 compared to Solodyn(R) | 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. | Time '0' to '72' hours after a single dose treatment |
| Area under the Curve (AUC0-inf) of DFD-29 compared to Solodyn(R) | 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. | Time '0' to '72' hours after a single dose treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events (AE) | Assessment and comparison between treatments of the number of participants with adverse events (AE). | Before and up to 14 days after the last dose study treatment |
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Inclusion Criteria:
1. Provision of signed and dated Informed Consent Form (ICF) 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Healthy adult male or postmenopausal females 4. If female, meets one of the following criteria:
Physiological postmenopausal status, defined as the following:
Surgical postmenopausal status, defined as the following:
Hysterectomy with FSH levels ≥ 40 mIU/mL at Screening If postmenopausal and has an FSH of < 40 mIU/mL, but meets all other criteria in (1),
(2), or (3) above as well as all the other inclusion criteria, Screening estradiol serum level must be equal to or below 150 pmol/L. In the case of hysterectomy, if FSH and estradiol do not meet the criteria, eligibility for study participation will be based on medical judgment. 5. If male, meets one of the following criteria:
Is able to procreate and agrees to use one of the accepted contraceptive regimens and not to donate sperm from the first study treatment administration to at least 90 days after the last study treatment administration. An acceptable method of contraception includes one of the following:
Is unable to procreate; defined as surgically sterile (i.e., has undergone a vasectomy at least 180 days prior to the first study treatment administration) 6. Aged at least 18 years but not older than 65 years 7. Body mass index (BMI) within 18.5 kg/m2 to 29.9 kg/m2, inclusively 8. Body weight greater than 50 kg 9. Non- or ex-smoker (An ex-smoker is defined as someone who completely stopped using nicotine products for at least 180 days prior to the first study treatment administration) 10. Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on the physical examination (including vital signs) and/or ECG, as determined by an Investigator.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Srinivas R Sidgiddi, M.D. | Journey Medical Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CRO | Québec | Canada |
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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.
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Laboratory personnel conducting the PK sample assessments are blinded to the treatments.
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| DFD-29 (Minocycline) Fed | Drug | 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. |
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| Solodyn (Minocycline) Fasting | Drug | 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. |
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|
| ID | Term |
|---|---|
| D008911 | Minocycline |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
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