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Belbuca 300 µg · 1 trial · 1 indication
Respiratory drive was evaluated by measuring the Ventilatory Response to Hypercapnia (VRH) through assessment of the maximum decrease (Emax) in minute ventilation (mL/min) after administration of Belbuca, Oxycodone hydrochloride, and placebo.
| Arm | Type | Description |
|---|---|---|
| Treatment A: Belbuca 300 µg and oral placebo | EXPERIMENTAL | Subjects treated with Belbuca 300 µg and oral placebo will be randomized to 1 of 6 treatment sequences in a 1:1:1:1:1:1 ratio. |
| Treatment B: Belbuca 600 µg and oral placebo | EXPERIMENTAL | Subjects treated with Belbuca 600 µg and oral placebo will be randomized to 1 of 6 treatment sequences in a 1:1:1:1:1:1 ratio. |
| Treatment C: Belbuca 900 µg and oral placebo | EXPERIMENTAL | Subjects treated with Belbuca 900 µg and oral placebo will be randomized to 1 of 6 treatment sequences in a 1:1:1:1:1:1 ratio. |
| Treatment D: Oxycodone 30 mg and buccal placebo | ACTIVE_COMPARATOR | Subjects treated with Oxycodone 30 mg and buccal placebo will be randomized to 1 of 6 treatment sequences in a 1:1:1:1:1:1 ratio. |
| Treatment E: Oxycodone 60 mg and buccal placebo | ACTIVE_COMPARATOR | Subjects treated with Oxycodone 60 mg and buccal placebo will be randomized to 1 of 6 treatment sequences in a 1:1:1:1:1:1 ratio. |
| Treatment F: Oral Placebo and buccal placebo | PLACEBO_COMPARATOR | Subjects treated with oral placebo and buccal placebo will be randomized to 1 of 6 treatment sequences in a 1:1:1:1:1:1 ratio. |
| Name | Type | Description |
|---|---|---|
| Belbuca 300 µg | DRUG | Belbuca 300 µg buccal film |
| Belbuca 600 µg | DRUG | Belbuca 600 µg buccal film |
| Belbuca 900 µg | DRUG | Belbuca 900 µg buccal film |
| Oxycodone 30 mg | DRUG | Oxycodone 30 mg capsule |
| Oxycodone 60 mg | DRUG | Oxycodone 60 mg capsule |
| Placebo | DRUG | placebo buccal film and oral placebo |
Inclusion Criteria: 1. Male or female subjects 18 to 55 years of age, inclusive. 2. Subjects are in good health as indicated by medical history, PE, vital signs, oxygen saturation, clinical laboratory tests, and 12-lead ECG. A status of good health will be defined by the absence of evidence of any ...
Belbuca 300 µg is an investigational small molecule being studied for the treatment of respiratory depression. It is currently in Phase 1 clinical development. The drug is being evaluated in a clinical trial that compares its effects on respiratory drive against oxycodone and placebo.
Belbuca 300 µg is being developed by Collegium Pharmaceutical, Inc., a company traded on the stock exchange under the ticker symbol COLL. The company is conducting clinical research to evaluate the drug's potential in treating respiratory depression.
Belbuca 300 µg is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied for its effects on respiratory depression in a clinical trial setting.
Belbuca 300 µg is being studied in a Phase 1 clinical trial with the identifier NCT03996694. This completed trial was a single-dose crossover study comparing the respiratory drive after administration of Belbuca, oxycodone, and placebo. The study enrolled 19 participants in the United States.
No, Belbuca 300 µg is not the same as oxycodone. Belbuca 300 µg is an investigational drug being studied for respiratory depression, while oxycodone is an opioid analgesic used in the clinical trial as a comparator. The trial was designed to compare the respiratory effects of these two drugs.