A Comparative Bioavailability/Food Effect Study of Immediate-Release and Extended-Release Tramadol HCl/Acetaminophen Combination Products Following Single-Dose and Multiple-Dose Administration in Healthy Adult Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objectives of this two-part study were to compare the single-dose and multiple-dose
      pharmacokinetics of extended release and immediate-release fixed combination formulations
      containing tramadol-HCl/acetaminophen and to evaluate the effect of food on the
      extended-release formulation.
    

Detailed description: 
      -  To compare the single (Part A) and multiple dose (Part B) pharmacokinetic profiles and
           bioavailability of DDS-06C tablets with the immediate-release tablet reference products
           Zaldiar® and Ultracet®.

        -  To assess the effect of food on the pharmacokinetic profile of DDS-06C tablets following
           administration of a single oral dose.

        -  To monitor and record all adverse events.
    

Intervention name(s): DDS-06C (650 mg acetaminophen and 75 mg tramadol HCl); DDS-06C (650 mg acetaminophen and 75 mg tramadol); Zaldiar®; Ultracet®; Two tablets of DDS-06C (650 mg acetaminophen and 75 mg tramadol HCl), multiple doses, under both fed and fasting conditions; Zaldiar®, multiple doses,(fed & fasting):; Ultracet®, multiple doses, (fed & fasting)
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): DDS-06C (650 mg acetaminophen and 75 mg tramadol HCl: two tablets, single dose, total administered of 1300 mg acetaminophen/150 mg tramadol HCl under fasting conditions; DDS-06C (650 mg acetaminophen and 75 mg tramadol HCl: two tablets, single dose, total administered of 1300 mg acetaminophen/150 mg tramadol HCl under fed conditions; Zaldiar® (325 mg acetaminophen and 37.5 mg tramadol HCl): two tablets; dose of 650 mg acetaminophen/75 mg tramadol HCl administered at Time = 0 hr (fasting)and second dose at Time = 6 hr (fed) Ultracet® (325 mg acetaminophen and 37.5 mg tramadol HCl); Ultracet® (325 mg acetaminophen and 37.5 mg tramadol HCl)two tablets; dose of 650 mg acetaminophen/75 mg tramadol HCl administered at Time = 0 hr (fasting)and second dose at Time = 6 hr (fed) Ultracet® (325 mg acetaminophen and 37.5 mg tramadol HCl); Two tablets of DDS-06C, twice daily at 12-hour intervals under fed conditions for the first 4 days, then under fasting conditions for the 5th day. The total daily dose administered was 2600 mg Acetaminophen/300 mg tramadol HCl; Two tablets of Zaldiar®, 4 times daily at 6-hour intervals under fed conditions for the first 4 days, then under fasting conditions for the 5th day. The total daily dose administered was 2600 mg Acetaminophen/300 mg tramadol HCl; Two tablets of Ultracet®, 4 times daily at 6-hour intervals under fed conditions for the first 4 days, then under fasting conditions for the 5th day. The total daily dose administered was 2600 mg Acetaminophen/300 mg tramadol HCl
Intervention MeSH terms: Acetaminophen; Tramadol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Tramadol; Acetaminophen; combination; pharmacokinetics; bioavailability; Zaldiar; Ultracet; fed; fasted; single-dose; multiple-dose; healthy; volunteers; Healthy volunteers