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Relatively few subjects (vestigator(s) StudyDates/Sites Study Design Regimen, Route end Dose* Number Treated Ag"(y) Range (Mean) M/F W/B/O In NDA Item/Volume/Page 0/2000/0-214(11 , * 6 Apr* 1985 Sin££* Center, US Randomized. open-tabel, crossover, bioavaiability stud)-. Five single doses; 1-week washout between doses Oral a^xazdam (IR and XR) dose of 1 mg 30 20-51 (29.9) 15/15 28/2/2 Rep: Item 6/Vot 6/Pg 90 M/2000/023S [21 w vJUiJUfl 1903 9 November 1965 Singte ininit it loc xanax Center. US Randomized, open-tabel, crossover bioavaiabffity stud]'. Fwe single doses; 1-week washout between doses Oral alprazolam (XR) dose of 1 mg [V alprazolam dose of 1 mg 28 22*53 (32.6) 14/14 26/2/0 Rep: Item 6/Vo! 8/Pg 1 22 February 1987 22 Uarch 1987 Sir^a Center, US Randomized, open-tabel, crossover, bioavaiabSity stud/ Free single doses; 1-week washout between doses ininit it loc xanax Oral alprazolam (IR and XR) dose of 1 and 2 mg 24 20-51 (29.7) 22/2 21/1/2 Rep: Item 6/Vd 9/Pg i uJvwuiWM 141 ^ 13 February 1987 15 Uarch 1987 Sin^s Center, US Randomized, open-label, crossover, b"oavaJab0ity study Five single doses; 1-week washout between doses Oral a^razdam (IR and XR) dose of 1 and 3 mg 24 24*55 (37-3) 14/10 22/1/1 Rep: Item 6/Vd 1(VPg 1 MftOOOIBSS [5] 24 rwnM; 10 Apri 1968 Single Center, US Randomized, cpeo-labd, pandlei group wwth a single dose phase and multiple doss phase Smgie dose IV treatment on day 1 Stn^e dose oral treatments on day 8, and then on days 10 • 12, doses atfrnnstered as a sngle dady dose x 3 days Oral alprazolam (XR) dose of 1,3 and A mg. Intravenous alprazolam dose of 1 mg. 42 18-54 (29.ininit it loc xanax 1) 42/0 26/16*0 Rep: Rem 6/Vol 13/Pg 1 •XR = afcxazotam sustained-rafease; IR = alprazolam compressed tablet (&nmodiate'raieese} APPEARS THIS WAY ON ORIGINAL Study No. [ref] investigators) Study Dates/Sites Siudy Design Subfects Report Location In NDA Hem/Volume/Page Regimen, Route and Dose* Number Treated Agefy) Range (Mean) M/F W/B/O U/2000/Q275 rsi lO M2TOI >900 2 April 1966 Single Center. OS Randomized, open-label, crossover, food eflect/bioavailability study Three single doses; 1-week washout between doses Oral alprazolam (IR and XR) does ol 1 mg . 21 21-43 (31) 12/9 20/cyi Rep: Item 6/Vol 16/Pg 129 U/20dMVttanR m 25 October 1966 8 November 1988 Sintfe Center. US Randomized, opervlabel, crossovif, bioequivalence study Four single doses; t-week washout between doses Oral alprazolam (IR and XR) dose of 1 mg 25 19-55 (32.8) 1W8 23/1/1 Rep: Item 8/Voi 14/Pg238 M/200WQ31A •*' c\ January 1963 17 February 1968 .

S'tn^e Center, US Randomized, opervtabei, crossover, bioequtvalence study Three single doses; 1-week washout between doses Oral a^xazotam (IR and XR) dose of 1 mg 24 18-39 (26.3) 24/0 2310/1 Rep: Item 6/Vol 15/Pg 1 16 October 1967 1 November 1967 Single Center. US Randomized, open-label, cross on >er, bioequivalence study Three single doses; 1 -week washout between doses Oral alprazolam (XR) dose of 6 ininit it loc xanax mg. 24 22-52 (34.8) 12/12 23/1/0 Rep: Hem 6/Vol 35/Pg 1 P/2002/0001 (10] 25 September 1989 31 October 1969 Single Center. US Randomized, open-label, •or, btoavaiabflity Five single doses; 1-week washout between doses Oral ajxazotam (XR) doses ot 1 and 3 mg 27 18-50 (31) 27/0 24/2/1 Rep: Item 6/Vol 38/Pg 1 APPEARS THIS WAY m ORIGINAL Table 1 Table of All Phase 1 Studies in the Integrated Summary of Safety Study No.

[ref] Investigators) Study Dates/Sites Study Design Subjects Report Location In NDA Item/Volume/Page Regimen, Route and Dose* Number Treated *9"{y) Range (Mean) M/F W/B/O SV90ft9/nnm mt 20 August 1988 10 September 1988 Single Center, US Randomzed, open-label, crosscver, bioavalabffrty study Four hydrocodone blurred vision single doses; 1-week washout betweon doses Oral a^jrazolam (XR) dose of 0.25. 0.5 and 1 mg 24 21-55 (38.1) 18/8 22W2 Rep: Item 6/Vol 11/Pg45 R/2002/0009 f"l Randomized, opervtabei, crossover, sto^e and multiple doses Single oral dose ol 2 x 3-mg XR tablets on Dayl and then once a day on days 3 through 8. Single oral dose of 1 x 1-mg and 1s 0.5-mg IR tablets on Day 1 and 4 times a day on days 3 through 8. 23 19-54 (32.1) 23/0 21/0/2 Rep: Item &Vol 17/Pg 1 za Apr* law 21 May 1989 Seigle Center, US RAM"nQM 1131 Double l&id, randomized modified 4-way crossover wdh placebo acfcnrttsterad in the first phase Four single doses; t wook washout between doses ininit it loc xanax Oral alprazolam (XR) dose of 2.4.



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