Evaluation of the pharmacokinetic profiles of the new testosterone topical gel formulation, Testim, compared to AndroGel.
A two-period, randomized, complete crossover study was performed to evaluate the pharmacokinetic profiles of Testim (AA2500), a new 1% testosterone topical gel formulation, compared to AndroGel, an already available 1% testosterone topical gel. Twenty-nine hypogonadal subjects received a single dose (50 mg testosterone) of each formulation seven days apart. C(max) estimates for total testosterone, dihydrotestosterone and free testosterone were greater (30, 19 and 38%, respectively) following the application of Testim compared to AndroGel. Similarly, AUC(0-24) estimates for total testosterone, dihydrotestosterone, and free testosterone were greater (30, 11 and 47%, respectively) following the application of Testim compared to AndroGel. Confidence intervals for C(max) and AUC(0-24) were not wholly contained within the bioequivalence limits for testosterone, therefore Testim trade mark and AndroGel are not bioequivalent with Testim providing higher serum levels and greater bioavailability than AndroGel.
Marbury
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T
Orlando Clinical Research Center, 4401 South Orange Avenue, Suite No. 108, FL 32806, USA. tmarbury@ocrc.net
Hamill
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E
Bachand
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R
Sebree
T
T
Smith
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T
D000287:Administration, Topical; D000368:Aged; D000704:Analysis of Variance; D019540:Area Under Curve; D002626:Chemistry, Pharmaceutical; D016001:Confidence Intervals; D018592:Cross-Over Studies; D015507:Drugs, Investigational / Q000008:administration & dosage* / Q000493:pharmacokinetics*; D005782:Gels; D006801:Humans; D007006:Hypogonadism / Q000097:blood / Q000188:drug therapy / Q000378:metabolism; D008297:Male; D008875:Middle Aged; D013739:Testosterone / Q000008:administration & dosage* / Q000097:blood / Q000493:pharmacokinetics*
D015507:Drugs, Investigational; D005782:Gels; D013739:Testosterone