A Single Dose Randomized Five-Way Crossover Pharmacokinetics (PK) Study of Tadalafil Semi-Chewable (Gummy) Formulations in Healthy Volunteers
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Erectile Dysfunction
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: Eligible subjects will receive a single oral dose of one of five treatments (Treatments A, B, C, D or E) in five separate periods in a randomly assigned sequence, with each treatment separated by an approximate 5-day washout period. In each study period, dosing will occur in the morning after an overnight fast of at least 10 hours. All doses will be administered under fasted conditions except for Treatment C, when tadalafil gummy 10 mg will be administered after consumption of a high-calorie, high-fat breakfast. All doses will be administered with approximately 240 mL of room temperature water except for Treatment D, when tadalafil gummy 10 mg dose will be administered without water. All doses of tadalafil gummy 10 mg will be chewed before swallowing except for Treatment E, when subjects will be instructed to swallow the dose whole.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 19 years and 65 years
- Gender
- Only males
Description
This is an open-label, single dose, randomized, five-period, crossover design study to evaluate the relative bioavailability of a single oral dose of tadalafil gummy 10 mg (Test) and tadalafil oral tablets 10 mg (Reference) under fasted conditions in healthy adult male and female subjects, and the i...
This is an open-label, single dose, randomized, five-period, crossover design study to evaluate the relative bioavailability of a single oral dose of tadalafil gummy 10 mg (Test) and tadalafil oral tablets 10 mg (Reference) under fasted conditions in healthy adult male and female subjects, and the impact on the bioavailability of tadalafil gummy sugar free 10 mg when administered with food, when administered with or without water, and when chewed or swallowed whole. Each subject will receive tadalafil gummy (10 mg) or tadalafil tablet and thereby will be his/hers own control.
Tracking Information
- NCT #
- NCT04762082
- Collaborators
- Not Provided
- Investigators
- Not Provided
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