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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.JP |
First Approval Date24 Mar 2014 |
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MechanismH1 receptor antagonists |
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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.DE |
First Approval Date16 Aug 2001 |
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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.US |
First Approval Date28 Feb 2001 |
A Randomized, Double-blind Trial Evaluating the Effects of Treatment With DFD-29 Capsules 40 mg QD in Comparison to Placebo on Microbial Flora in Healthy Adult Human Subjects, When Administered Over a Period of 16 Weeks.
The purpose of this trial is to evaluate the effects of 16-week treatment with DFD-29 40 mg QD dose in comparison to Placebo on the skin, intestinal and vaginal microbiota.
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
Single-center, randomized, open-label, laboratory-blinded, 3-treatment, 3-period, 6-sequence, single-dose, crossover study.
A Multicenter, Randomized, Double-Blind, Parallel-Group, Active and Placebo Controlled Study to Assess the Safety, Efficacy and Tolerability of Oral DFD-29 Extended Release Capsules for the Treatment of Inflammatory Lesions of Rosacea Over 16 Weeks
This is a 16-week, multicenter, randomized, parallel-group, double-blind, controlled study. After assessing eligibility during a screening period of up to 30 days, approximately 320 subjects at least 18 years old who are diagnosed with moderate to severe papulopustular rosacea will be randomized in a 3:3:2 ratio to DFD-29 (40 mg), Doxycycline capsules 40 mg, or Placebo once daily for 16 weeks. Of the 320 subjects, approximately 160 subjects are planned to be enrolled at 15 sites in the US, while the remaining subjects are to be enrolled at 14 sites in the EU.
100 Clinical Results associated with Dr. Reddy's Laboratories Ltd. (Russia)
0 Patents (Medical) associated with Dr. Reddy's Laboratories Ltd. (Russia)
100 Deals associated with Dr. Reddy's Laboratories Ltd. (Russia)
100 Translational Medicine associated with Dr. Reddy's Laboratories Ltd. (Russia)