Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 an investigational small molecule being studied for pharmacokinetics. It is currently in Phase 1 clinical development. A completed trial compared DFD-29 capsules 40 mg versus SOLODYN tablets 105 mg under fasting and fed conditions in healthy adult subjects.
The molecular target for DFD-29 Fasting has not been disclosed. The available information describes it as a small molecule in Phase 1 development for pharmacokinetic studies, but does not specify its mechanism of action or biological target.
DFD-29 Fasting is being developed by Journey Medical Corporation, which trades under the ticker DERM. The company is conducting clinical trials for this investigational small molecule.
DFD-29 Fasting is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed, with no active trials currently listed.
DFD-29 Fasting has one completed clinical trial, NCT05452785, which was a comparative bioavailability study of DFD-29 capsules 40 mg versus SOLODYN tablets 105 mg under fasting and fed conditions. The study enrolled 24 healthy adult subjects in Canada.
No, DFD-29 Fasting is not the same as SOLODYN. In the clinical trial NCT05452785, DFD-29 capsules 40 mg were compared against SOLODYN tablets 105 mg as an active control. DFD-29 is an investigational product, while SOLODYN is a reference drug.