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A Single Dose, Randomized, Open-label, Two-way Crossover Bioequivalence Study of Tadalafil 5 mg Film-coated Tablets (CASEY 5) and Reference Product (Cialis 5 mg) in Healthy Thai Male Volunteers under Fasting Conditions

A Single Dose, Randomized, Open-label, Two-way Crossover Bioequivalence Study of Tadalafil 5 mg Film-coated Tablets (CASEY 5) and Reference Product (Cialis 5 mg) in Healthy Thai Male Volunteers under Fasting Conditions

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
TCTR
Registry ID
TCTR20230331004
Enrollment
34
Registered
2023-03-31
Start date
2023-06-26
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Thai Male Volunteers Healthy Thai Male Volunteers

Interventions

Reference Product, Tadalafil 5 mg film-coated tablet, Trade name Cialis 5 mg, Lot No. D541622, Manufactured by Lilly Del Caribe Inc., Carolina, PR00985, Puerto Rico.,Test product, Tadalafil 5 mgfilm-c
Active Comparator Drug,Experimental Drug
Reference Product,Test Product

Sponsors

Macrophar CO., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: Healthy Thai Male Volunteers

Exclusion criteria

Exclusion criteria: 1. History of allergic reaction or hypersensitivity to tadalafil 2. Have high risk for COVID-19 or diagnosed as confirmed case of COVID-19

Design outcomes

Primary

MeasureTime frame
PK parameter (Fasting condition) 0.00 (pre-dose) and at 0.16, 0.33, 0.50, 0.75, 1.00, 1.33, 1.67, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 6.00, 8.00, 12.00, 24.00, 48.00 and 72.00 hours post-dose. Phoenix WinNonlin software, Version 8.3 or above.—

Secondary

MeasureTime frame
PK Parameter (Fed condition) 0.00 (pre-dose) and at 0.33, 0.67, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.33, 3.67, 4.00, 4.50, 5.00, 6.00, 8.00, 12.00, 24.00, 48.00 and 72.00 hours post-dose. Phoenix WinNonlin software, Version 8.3 or above.—

Countries

Thailand

Contacts

Public ContactKitsana Poopanit Upatum

International Bio Service Co., Ltd.

kitsana.poo@mahidol.ac.th6624425211

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026