Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as DFD-29 (Minocycline) Fasting
DFD-29 Fasting · 1 trial · 1 indication
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) - 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.
| Arm | Type | Description |
|---|---|---|
| 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 |
|---|---|---|
| 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. |
| 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. |
| 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. |
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: 1. Physiolog...
DFD-29 Fasting is the fasting-condition arm of a Phase 1 bioavailability study of DFD-29, an oral minocycline capsule developed by Journey Medical Corporation. The study compared DFD-29 capsules 40 mg with SOLODYN tablets 105 mg in healthy adult volunteers under fasting and fed conditions.
DFD-29 is being developed by Journey Medical Corporation, which trades on the Nasdaq under the ticker DERM. The company sponsored the Phase 1 comparative bioavailability study of the DFD-29 capsule formulation.
DFD-29 Fasting has been evaluated in a Phase 1 clinical trial. The single registered study, NCT05452785, is completed. DFD-29 remains an investigational product and is not approved by the FDA based on this Phase 1 bioavailability work.
DFD-29 Fasting was studied in NCT05452785, a completed Phase 1 comparative bioavailability trial. It enrolled 24 healthy adult volunteers in Canada and compared DFD-29 capsules 40 mg with SOLODYN tablets 105 mg under fasting and fed conditions. The trial was randomized and active controlled.
Yes. DFD-29 Fasting and DFD-29 (Minocycline) Fasting refer to the same product and study arm. DFD-29 is an oral minocycline small molecule, and the fasting designation describes the dosing condition used in the Phase 1 bioavailability trial.
DFD-29 is a small molecule minocycline product. The Phase 1 trial NCT05452785 evaluated its pharmacokinetics and comparative bioavailability rather than a molecular target, enrolling healthy adult volunteers to compare DFD-29 capsules 40 mg with SOLODYN tablets 105 mg.