NCT03905564

A Study to Investigate Differences in the Extent and Rate of Absorption of Doxylamine/Pyridoxine From 2 Different Products Under Fasting Conditions

Single Site, Open-label, Randomized, Two Treatments, Two Periods, Two Sequences, Crossover Trial to Evaluate the Bioequivalence of Two Delayed-release Oral Formulations of a Fixed Combination of Doxylamine Succinate 10 mg/Pyridoxine Hydrochloride 10 mg (Test Product: Product of Tecnandina, S.A. TENSA; Reference Product: Diclegis (Registered Trademark) Product of Duchesnay Inc.) After a Single Administration of Two Tablets to Healthy Women Under Fasting Conditions

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Grünenthal GmbH · Industry
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to investigate any difference in the extent and rate of absorption of doxylamine between the test (investigational medicinal product \[IMP\]) and reference products that could impact the bioavailability of the medication when administered under fasting conditions.

Detailed description

The objective of the study is to compare the bioavailability of doxylamine between two oral delayed-release formulations containing the fixed-dose combination of doxylamine succinate 10 milligrams (mg)/pyridoxine hydrochloride 10 mg * A product of Tecnandina, S.A. TENSA (Test) and * Diclegis (Registered Trademark), a product of Duchesnay Inc.(Reference) after an administration of a single dose equivalent to doxylamine succinate 20 mg and pyridoxine hydrochloride 20 mg (i.e., 2 tablets) under fasting conditions to determine bioequivalence in terms of rate and extent of absorption. Furthermore, the tolerability of the fixed-dose combination doxylamine succinate 10 mg/pyridoxine hydrochloride 10 mg will be evaluated in healthy women in a dose equivalent to doxylamine succinate 20 mg and pyridoxine hydrochloride 20 mg.

Conditions

• Bioavailability

Interventions

Type	Name	Description
DRUG	doxylamine succinate 10 mg/pyridoxine hydrochloride 10 mg combination	Delayed-release tablet containing a fixed-dose combination of doxylamine succinate 10 mg and pyridoxine hydrochloride 10 mg (product of Tecnandina, S.A. TENSA).
DRUG	Diclegis (Registered Trademark)	Delayed-release tablet containing a fixed-dose combination of doxylamine succinate 10 mg and pyridoxine hydrochloride 10 mg (product of Duchesnay Inc.).

Timeline

• Start date: 2019-06-01
• Primary completion: 2020-06-01
• Completion: 2020-06-01
• First posted: 2019-04-05
• Last updated: 2019-07-11