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

NCT03905564 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2019-07-11

No results posted yet for this study

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.

Conditions

  • Bioavailability

Interventions

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.).

Sponsors & Collaborators

  • Grünenthal, S.A.

    collaborator INDUSTRY

  • Grünenthal GmbH

    lead INDUSTRY

Principal Investigators

  • Study Director · Grünenthal GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-06-30
Primary Completion
2020-06-30
Completion
2020-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03905564 on ClinicalTrials.gov