Bioequivalence and Bioavailability Forum

Mahesh M ★ India, 2014-07-15 14:59 (4362 d 10:20 ago) Posting: # 13265 Views: 6,627	bioequivalence study design of vaginal ring [Design Issues] Post reply
	Dear All, Any one suggests me about bioequivalence study design of vaginal ring (contraceptive ring). Any supportive literature? Regards

ElMaestro ★★★ Denmark, 2014-07-15 15:44 (4362 d 09:35 ago) @ Mahesh M Posting: # 13266 Views: 5,689	bioequivalence study design of vaginal ring Post reply
	Hi Mahesh, need to know the actual product and the country of submission. For starters, how about this? And this one for further inspiration? — Pass or fail! ElMaestro

Mahesh M
★

India,
2014-07-16 09:06
(4361 d 16:13 ago)

@ ElMaestro
Posting: # 13272
Views: 5,684

bioequivalence study design of vaginal ring

Post reply

Hi ElMaestro,

That’s nice, actually I work on Ethinyl Estradiol; Etonogestrel (0.015 mg/24 hr; 0.12 mg/24 hr) for US submission.

Dose: single ring for 21 days (Per day ring release 0.015 mg EE and 0.12 mg Etonogestrel) “that mean is like a multiple dose study“ ?

Draft guidance mentioned:

Two way cross over

Bioequivalence based on (90% CI): Ethinyl estradiol and etonogestrel

What is the primary PK parameters ? is it Cmax, AUC0-t and AUC0-∞ or Css (Steady state parameters ) ?

What’s the sampling schedule for this study ?

Regards
Mahesh

luvblooms
★★

India,
2014-07-16 10:12
(4361 d 15:07 ago)

@ Mahesh M
Posting: # 13273
Views: 5,788

bioequivalence study design of vaginal ring

Post reply

Dear Mahesh

Just one point to clarify

❝ Dose: single ring for 21 days( Per day ring release 0.015 mg EE and 0.12 mg Etonogestrel) “that mean is like a multiple dose study“ ?

Nope, it does not mean like multiple dose study, it would be like controlled release formulation releasing drug as a zero order release at the rate of 0.015 mg/24 hr and/or 0.12 mg/24 hr. (You can assume it similar to that of any long acting IM injections)

❝ Draft guidance mentioned:

❝ Two way cross over

❝ Bioequivalence based on (90% CI): Ethinyl estradiol and etonogestrel

❝ What is the primary PK parameters ? is it Cmax, AUC0-t and AUC0-∞ or Css (Steady state parameters) ?

❝ What’s the sampling schedule for this study ?

For study related details look for following papers

PHARMCOKINETICS OF 3-KETO-DESCZESTREL AND ETHINYLESTRADIOL RELEASED FROH DIFFERENT TYPES OF CONTRACEP VANGINAL RINGS C.J. Timmer, D.Apter and G. Voortman, Contraception DECEMBER 1990 VOL. 4 NO. 6
Comparison of ethinyl estradiol pharmacokinetics in three hormonal contraceptive formulations: the vaginal ring, the transdermal patch and an oral contraceptive, Contraception 72 (2005) 168–174
Pharmacokinetics of Etonogestrel and Ethinylestradiol Released from a Combined Contraceptive Vaginal Ring. Clinical Pharmacokinetic 2000 Sep; 39 (3): 233-242
Absence of Pharmacokinetic Interactions of the Combined Contraceptive Vaginal Ring NuvaRing with Oral Amoxicillin or Doxycycline in Two Randomised Trials; Clin Pharmacokinet 2005; 44 (4)

Also check Drugs@Fda look for page 17 onwards.

Hope this would be of some use.

—
~A happy Soul~

Mahesh M ★ India, 2014-07-16 10:52 (4361 d 14:26 ago) @ luvblooms Posting: # 13274 Views: 5,621	bioequivalence study design of vaginal ring Post reply
	Dear luvblooms, Thank you so much for your valuable response. Regards M

bioequivalence study design of vaginal ring [Design Issues]

bioequivalence study design of vaginal ring

bioequivalence study design of vaginal ring

bioequivalence study design of vaginal ring

bioequivalence study design of vaginal ring