Bioavailability Clinical Trial
Official title:
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
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.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT06043739 -
Relative Bioavailability and Effect of Food Study With an Oral Mini-tablet Formulation of Filgotinib in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT02557139 -
Bioavailability of Belumosudil (KD025) in Healthy Male Subjects
|
Phase 1 | |
| Completed |
NCT02010944 -
A Study to Compare How Much Solifenacin Succinate and Mirabegron Reach the Blood When Administered Together as Fixed-dose Combination Tablets and With Single Individual Tablets of the Same Medications at Three Dose Levels
|
Phase 1 | |
| Completed |
NCT01208155 -
Study in Healthy Males to Assess Bioavailability of 4 Different Fostamatinib Tablets
|
Phase 1 | |
| Not yet recruiting |
NCT01136551 -
Comparative Bioavailability Study of an Immediate Release and Controlled Release Oral Formulations of Huperzine A
|
N/A | |
| Completed |
NCT04097808 -
Impact of the Source and Food Matrices on the Bioavailability of Peptan® (Collagen Peptides) in Healthy Subjects
|
N/A | |
| Active, not recruiting |
NCT06098001 -
Bioavailability Study of Hemp Phenolics
|
N/A | |
| Completed |
NCT01912144 -
Absorption of Phenolic Acids From Coffee in Humans
|
N/A | |
| Completed |
NCT03915626 -
Effect of Heat on Rivastigmine TDS Products
|
Early Phase 1 | |
| Completed |
NCT01448772 -
Comparative Bioavailability of Dronabinol Oral Solution Versus Branded Capsule 5 mg Under Fasting Conditions
|
Phase 1 | |
| Completed |
NCT01464450 -
Pharmacokinetics Study of Oral Rivaroxaban in Healthy Participants
|
Phase 1 | |
| Completed |
NCT01181973 -
Safety, Tolerability and Relative Bioavailability of Pegvisomant in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT00858767 -
Arabic Gum-Absorption Study
|
N/A | |
| Completed |
NCT04113564 -
Absolute Oral Bioavailability of Remimazolam
|
Phase 1 | |
| Completed |
NCT04645394 -
Bioavailability of Anthocyanins From Aronia Extract in Healthy Men - a Pilot Study
|
N/A | |
| Completed |
NCT03485885 -
Bioavailability of Maqui Berry Extract (MBE) in Healthy Subjects
|
||
| Completed |
NCT05840848 -
Effect of Iron and Zinc Supplementation on B-carotene Bioavailability in Healthy Males
|
N/A | |
| Completed |
NCT02986529 -
A Study to Assess the Bioavailability of Oral Sodium Oligo-mannurarate (GV-971) in Healthy Chinese Male Subjects
|
Phase 1 | |
| Completed |
NCT01789359 -
Urinary Excretion of Anthocyanins During Long Term Blueberry Feeding
|
N/A | |
| Completed |
NCT01638143 -
Bio-equivalence Study
|
N/A |