The purpose of this study was to compare the pharmacokinetic profiles at steady-state of the test product, Tramadol HCl Once-A-Day (OAD) 200 mg tablets and the reference product, Tramadol HCl 50 mg (IR) tablets (Ortho-McNeil Ultram®). For this purpose, the extent of absorption of tramadol and formation of O-desmethyltramadol (measures of systemic exposure) after multiple administration of 50 mg 6-hourly at 07:30, 13:30, 19:30 and 01:30 (reference product) and 200 mg 24-hourly at 07:30 (test product), were compared.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
26
1x200 mg Tramadol HCl OAD tablet daily
1x50 mg Tramadol HCl IR (Ultram®) tablet 6-hourly
Area Under the Plasma Concentration Versus Time Data Pairs at Steady State (AUCss)
Area under the plasma concentration versus time data pairs over 24 hours (24h) at steady state, on day 5. ss = steady state. AUCss is also known as AUCtau.
Time frame: 24 hours (day 5)
Maximum Plasma Concentration at Steady State(Cmax,ss)
Maximum plasma concentration over 24 hours (24h) at steady state, on day 5. ss = steady state.
Time frame: 24 hours (day 5)
Minimum Plasma Concentration at Steady State(Cmin,ss)
Minimum plasma concentration over 24 hours (24h) at steady state on day 5. ss = steady state.
Time frame: 24 hours (day 5)
Time to Peak Exposure (Tmax)
Time to peak exposure over 24 hours (24h) at steady state on day 5.
Time frame: 24 hours (day 5)
Percentage Peak-trough Fluctuation (% PTF)
Percentage peak-trough fluctuation over 24 hours (24h) at steady state on day 5. Percent peak-to-trough fluctuation is calculated as (Cmax - Cmin)/Cav\*100, where Cmax is the maximum observed concentration, Cmin is the minimum observed concentration and Cav is the average concentration over 24 hours (where Cav = AUCss/24).
Time frame: 24 hours (day 5)
Percentage Swing
Percentage swing is a pharmacokinetic parameter recommended by the FDA for submission and is calculated as follows:((Cmax,ss - Cmin,ss)/Cmin,ss)\*100. It was calculated over 24 hours on day 5. Where: Cmax,ss = Maximum concentration at steady state; Cmin,ss = Minimum concentration at steady state.
Time frame: 24 hours (day 5)
Half-value Duration (HVD)
Time over which plasma concentrations were above one half Cmax on day 5. 24h = 24 hours.
Time frame: 24 hours (day 5)
Plateau Time (T75%Cmax)
Time over which plasma concentrations were above 75% Cmax on day 5. 24h = 24 hours.
Time frame: 24 hours (day 5)
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