A randomized, single-site, open-label, 2-way crossover, single-dose Phase I clinical trial to assess the bioequivalence of 2 tablets of a tapentadol 25 mg prolonged-release tablet formulation and 1 tablet of a tapentadol 50 mg prolonged-release tablet formulation in healthy male subjects under fed conditions

A randomized, single-site, open-label, 2-way crossover, single-dose Phase I clinical trial to assess the bioequivalence of 2 tablets of a tapentadol 25 mg prolonged-release tablet formulation and 1 tablet of a tapentadol 50 mg prolonged-release tablet formulation in healthy male subjects under fed conditions - BE Tapentadol

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON46632

Enrollment

Registered

2018-04-05

Start date

2018-05-07

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

chronische pijn bij volwassenen chronic pain in adults

Interventions

The volunteer will receive tapentadol as 1 tablet (50 mg, reference formulation) and 2 tablets (25 mg each, test formulation) with 240 milliliter (mL) of tap water. The volunteer will receive the s

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: -Healthy male subjects -18-55 yrs, inclusive -BMI: 20.0-28.0 kg/m2, inclusive, with a body weight of no less than 50 kg. -non-smoking or light-smoking

Exclusion criteria

Exclusion criteria: Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 30 days from the start of the study. In case of donating more than 500 ml of blood in the 3 months prior the start of this study.;Evidence or history of alcohol or drug abuse including positive or missing alcohol urine test or drugs of abuse test.

Design outcomes

Primary

Measure	Time frame
To demonstrate the bioequivalence of 2 tablets of a tapentadol prolongedrelease (PR) 25 mg tablet formulation and 1 tablet of a tapentadol PR 50 mg tablet formulation after single oral administration under fed conditions. Primary pharmacokinetic outcome parameters are AUC (AUC0-inf), AUC0-t, and Cmax.	—

Secondary

Measure	Time frame
To assess further pharmacokinetic parameters (tmax, tlag, tlast, MRT, HVD, CL/f, Vz/f, AUC%extr, t1/2,z, and partial AUC (AUC0-6 h). To assess the safety and tolerability of both treatments (occurrence of adverse events).	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)