A Study to Compare the Bioavailability of Two Tramadol Hydrochloride Tablet Products (50 mg and 200 mg, Respectively) at Steady-state Under Fasting Conditions
This study has been completed.
Information provided by (Responsible Party):
First received: January 30, 2009
Last updated: April 24, 2012
Last verified: April 2012
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.
Drug: Tramadol HCl
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Study to Compare the Bioavailability of Two Tramadol Hydrochloride Tablet Products (50 mg and 200 mg, Respectively) at Steady-state Under Fasting Conditions
Primary Outcome Measures:
- Area Under the Plasma Concentration Versus Time Data Pairs at Steady State (AUCss) [ Time Frame: 24 hours (day 5) ] [ Designated as safety issue: No ]
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.
Secondary Outcome Measures:
- Maximum Plasma Concentration at Steady State(Cmax,ss) [ Time Frame: 24 hours (day 5) ] [ Designated as safety issue: No ]
Maximum plasma concentration over 24 hours (24h) at steady state, on day 5. ss = steady state.
- Minimum Plasma Concentration at Steady State(Cmin,ss) [ Time Frame: 24 hours (day 5) ] [ Designated as safety issue: No ]
Minimum plasma concentration over 24 hours (24h) at steady state on day 5. ss = steady state.
- Time to Peak Exposure (Tmax) [ Time Frame: 24 hours (day 5) ] [ Designated as safety issue: No ]
Time to peak exposure over 24 hours (24h) at steady state on day 5.
- Percentage Peak-trough Fluctuation (% PTF) [ Time Frame: 24 hours (day 5) ] [ Designated as safety issue: No ]
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).
- Percentage Swing [ Time Frame: 24 hours (day 5) ] [ Designated as safety issue: No ]
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.
Cmax,ss = Maximum concentration at steady state; Cmin,ss = Minimum concentration at steady state.
- Half-value Duration (HVD) [ Time Frame: 24 hours (day 5) ] [ Designated as safety issue: No ]
Time over which plasma concentrations were above one half Cmax on day 5. 24h = 24 hours.
- Plateau Time (T75%Cmax) [ Time Frame: 24 hours (day 5) ] [ Designated as safety issue: No ]
Time over which plasma concentrations were above 75% Cmax on day 5. 24h = 24 hours.
| Study Start Date:
| Primary Completion Date:
||August 2003 (Final data collection date for primary outcome measure)
Experimental: 1: 1x200 mg Tramadol HCl OAD tablet daily
Drug: Tramadol HCl
1x200 mg Tramadol HCl OAD tablet daily
Active Comparator: 2: 1x50 mg Tramadol HCl IR (Ultram®) tablet 6-hourly
Drug: Tramadol HCl
1x50 mg Tramadol HCl IR (Ultram®) tablet 6-hourly
|Ages Eligible for Study:
||18 Years to 55 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Evidence of psychiatric disorder, antagonistic personality, poor motivation, emotional or intellectual problems likely to limit the validity of consent to participate in the study or limit the ability to comply with protocol requirements.
- History of, or current compulsive alcohol abuse (> 10 drinks weekly), or regular exposure to other substances of abuse.
- Use of any medication, prescribed or over-the-counter, within 2 weeks prior to the first administration of study medication except if this would not have affected the outcome of the study in the opinion of the clinical investigator. Use of hormonal contraceptives agents by females was not allowed.
- Participation in another study with an experimental drug within 8 weeks before the first administration of study medication.
- Treatment within the previous 3 months with any drug with a well-defined potential for adversely affecting a major organ or system with evidence to this effect.
- Major illness during the 3 months before commencement of the screening period.
- History of hypersensitivity to the study drug or any related drugs.
- History of bronchial asthma.
- History of epilepsy.
- Relevant history or laboratory or clinical findings indicative of acute or chronic disease, likely to influence study outcome.
- Donation or loss of blood equal to or exceeding 500 ml during the 8 weeks before the first administration of study medication.
- Diagnosis of hypotension made during the screening period.
- Diagnosis of hypertension made during the screening period or current diagnosis of hypertension.
- Resting pulse of > 100 beats per minutes or < 45 beats per minutes during the screening period, either supine or standing.
- Positive testing for hepatitis B antigen.
- Significant liver disease, defined as active hepatitis or elevated liver enzymes (e.g., AST, ALT) > 3 times the upper boundary of the normal range.
- Positive urine screen for drugs of abuse.
- Positive urine screen for tobacco use.
- History of marijuana, barbiturates, amphetamine, or narcotic abuse within 12 months prior to study start.
- Previous participation in a tramadol study.
- pregnancy or lactation.
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History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 30, 2009
|Results First Received:
||April 8, 2009
||April 24, 2012
||South Africa: Medicines Control Council
Keywords provided by Labopharm Inc.:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 24, 2016
Central Nervous System Depressants
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sensory System Agents