What type of study is this?

This is a Human Clinical Trial study (also classified as: Pre-Registered Trial).

What question did this study set out to answer?

To determine if tadalafil oral soluble film is bioequivalent to tadalafil tablets.

December 8, 2025Clinical and Translational ScienceOpen Access

Bioequivalence Study of Tadalafil Oral Soluble Film and Tadalafil Tablet in Healthy Chinese Volunteers Under Fasting Conditions

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Authors

XJXin Jiang FSFeifei SunQingdao University YXYi XuAcademy of Medical Sciences

Discussion

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Implication

Clinical study finds tadalafil oral soluble film bioequivalent to tablets in healthy volunteers under fasting conditions, suggesting comparable safety profiles.

Key Points

To determine if tadalafil oral soluble film is bioequivalent to tadalafil tablets.
Conducted a clinical study in healthy Chinese male volunteers under fasting conditions.
Participants received either a tadalafil tablet, a tadalafil OSF with water, or an OSF without water in each period.
Plasma concentrations of tadalafil were analyzed using liquid chromatography tandem mass spectrometry.
Primary pharmacokinetic parameters demonstrated bioequivalence between the OSF and tablet formulations.
The 90% confidence intervals for geometric mean ratios of PK parameters fell within the bioequivalence range of 80.00%-125.00%.
Adverse events reported were mild to moderate, with no serious adverse events noted.

Cite This Study

Jiang et al. (2025) studied this question.

synapsesocial.com/papers/693624a44fa91c937236c3aa https://doi.org/10.1111/cts.70440

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Implication

Clinical study finds tadalafil oral soluble film bioequivalent to tablets in healthy volunteers under fasting conditions, suggesting comparable safety profiles.

Bioequivalence Study of Tadalafil Oral Soluble Film and Tadalafil Tablet in Healthy Chinese Volunteers Under Fasting Conditions

Discussion

Member takes

Implication

Key Points

Cite This Study

Bioequivalence Study of Tadalafil Oral Soluble Film and Tadalafil Tablet in Healthy Chinese Volunteers Under Fasting Conditions

Discussion

Member takes

Implication

Key Points

Cite This Study

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