NCT05182047

A Study of Butamirate Citrate Syrup Versus (vs) Sinecod Syrup (Vanilla) in Adult Healthy Study Volunteers

A Randomized, Open, Crossover, Single Dose, Bioequivalence Study of a Novel Medication Butamirate Citrate Syrup 1.5 mg/mL (McNeil Iberica S.L.U., Spain) vs. Sinecod Syrup (Vanilla) 1.5 mg/mL (GSK Consumer Healthcare S.A., Switzerland), in Adult Healthy Study Volunteers

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: McNeil AB · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate bioequivalence with respect to rate and extent of absorption of 2-phenylbuturic acid of the novel medication butamirate citrate syrup 1.5 milligrams per milliliter (mg/mL), and the medication sinecod syrup (vanilla) 1.5 mg/mL after single-dose administration in fasting condition by healthy volunteers.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Butamirate citrate	Butamirate citrate syrup will be administered orally.
DRUG	Sinecod	Sinecod syrup will be administered orally.

Timeline

• Start date: 2022-03-18
• Primary completion: 2022-05-05
• Completion: 2022-05-05
• First posted: 2022-01-10
• Last updated: 2022-05-20

Locations

1 site across 1 country: Russia