Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Guaifenesin and Pseudoephedrine 1200 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Guaifenesin and Pseudoephedrine Hydrochloride ER Tablets | EXPERIMENTAL | Guaifenesin and Pseudoephedrine Hydrochloride ER Tablets 1200/120 mg of Dr. Reddy's Laboratories Limited |
| Mucinex D | ACTIVE_COMPARATOR | Mucinex D extended-release bi-layer tablets 1200/120 mg of Reckitt Benckiser Inc., USA |
| Name | Type | Description |
|---|---|---|
| Guaifenesin and Pseudoephedrine Hydrochloride Extended Release Tablets 1200/120 mg | DRUG | - |
Inclusion Criteria: i. Volunteers who provide written informed consent. ii. Must be healthy, adult, humans between 18 and 45 years of age (both inclusive) weighing at least 55 kg. iii. Having a body mass index between 18.5 and 24.9 (both inclusive), calculated as weight in Kg/height in m2. iv. M...
Guaifenesin and Pseudoephedrine 1200 is an extended release tablet combination of guaifenesin and pseudoephedrine hydrochloride in 1200 mg and 120 mg strengths. It is being developed by Dr. Reddy's Laboratories Ltd under ticker RDY. The product is a small molecule candidate that has been studied in a bioequivalence trial in healthy volunteers.
Guaifenesin and Pseudoephedrine 1200 is developed by Dr. Reddy's Laboratories Ltd, which trades under the ticker RDY. The company sponsored the bioequivalence study of the extended release tablets conducted in India.
Guaifenesin and Pseudoephedrine 1200 is in Phase 1 development. One Phase 1 trial has been completed, and no trials are currently active. The completed study was a bioequivalence trial rather than an efficacy study, so the program remains in clinical development.
Guaifenesin and Pseudoephedrine 1200 has been studied in one completed Phase 1 trial, NCT03706300, titled Bioequivalence Study of Guaifenesin and Pseudoephedrine Hydrochloride Extended Release Tablets 1200/120 mg Under Fasting Conditions. The trial enrolled 80 healthy male volunteers aged 18 years and older in India and used an active controlled, randomized design.
The intended indication for Guaifenesin and Pseudoephedrine 1200 has not been disclosed. The only completed trial, NCT03706300, was a bioequivalence study conducted in healthy male volunteers under fasting conditions, so it evaluated drug exposure rather than a specific disease or symptom.