Pharmacokinetics Clinical Trial
Official title:
Study of Non-pharmacokinetic Interaction Between Diclofenac 25 mg and 25 mg Tramadol With the Fixed-dose Combination Tablets of the Two Drugs Administered to Healthy Subjects of Both Genders in Fasting State
The objective of the study was to evaluate whether or not there is a substantial pharmacokinetic interaction between diclofenac and tramadol in a new formulation of a fixed-dose combination of diclofenac 25 milligrams (mg) and tramadol 25 mg for oral administration. The study was conducted in healthy participants of both genders.
After a screening period of about 2 weeks, 36 eligible healthy men and women were randomly
allocated to receive 3 sequential treatments in the following order:
- a single dose of diclofenac followed by a single dose of the fixed-dose combination of
diclofenac/tramadol followed by a single dose of tramadol
- a single dose of tramadol followed by a single dose of the fixed-dose combination of
diclofenac/tramadol followed by a single dose of diclofenac.
There were washout periods of 7 days between treatments.
Sixteen blood samples were collected per participant: at pre-dose and 0.16, 0.33, 0.5, 0.75,
1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 and 36 hours after administration of each of the study
drugs.
The pharmacokinetic parameters and relative bioavailabilities of diclofenac and tramadol (and
of the tramadol metabolite M1) were determined for the new fixed-dose combination product and
were compared to the single compound reference products.
Furthermore, the safety (frequency of adverse events) and tolerability of the new fixed-dose
combination of diclofenac 25 mg and 25 mg tramadol in healthy men and women was assessed.
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