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More info
You can access this
clinical trial
if you have
Anxiety Disorders
and you are
between 18 and 40
years old
1
This is an early phase trial to determine
the dosage and safety of the new treatment.
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The purpose

The objective of this study was to confirm if two formulations of alprazolam (tablets) are bioequivalent. Test product was Zamoprax® 2 mg (GlaxoSmithKline) and reference product Tafil® 2 mg (Pharmacia & Upjohn). One tablet was the single dosage. The study was prospective, open-label, randomized, crossover, single dose, with 02 treatments, 02 sequences and 02 periods, under fasting conditions. The population was composed of 26 healthy volunteers, both genders, adults between 18-50 years. The comparative bioavailability of the two formulations was evaluated based in statistical comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations in blood.

Provided treatments

  • Drug: Alprazolam 2mg tablets
  • Drug: Alprazolam 2 mg tablets

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT01745575. The sponsor of the trial is GlaxoSmithKline and it is looking for 26 volunteers for the current phase.
Official trial title:
Open, Two Periods, Two Treatments, Two Sequences, Cross-over, Randomized Trial With Single Dosageof Two Oral Preparations Containing 2 mg of Alprazolam (Zamoprax GlaxoSmithKline México, S.A. de C.V. vs. Tafil 2.0 mg, Pharmacia &Upjohn, S.A. de C.V.) in Fasting Healthy Volunteers