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Dutasteride is indeed in phase 3 trials in KOREA

» Bryan, I don’t know how you can compare b-12 absorption to dutasteride
» without knowing the molecular size and weight of each. It appears that
» dutasteride readily crosses the dermis. duta 528 daltons, b-12 breaks the
» 500 dalton rule by 2.5 times with over a 1300 dalton weight.

I wouldn’t assume that the absortption of substances through tissues of the mouth follows the 500-Dalton rule, any more than I would assume that absorption of food across the intestinal lining (as in EATING FOOD the normal way) follows that same rule! :slight_smile:

In other words, the 500-Dalton rule is a general rule-of-thumb for the likelihood of substances to pass through the SKIN specifically. I don’t know how relevant it is for anything else.

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» » Bryan, I don’t know how you can compare b-12 absorption to dutasteride
» » without knowing the molecular size and weight of each. It appears that
» » dutasteride readily crosses the dermis. duta 528 daltons, b-12 breaks
» the
» » 500 dalton rule by 2.5 times with over a 1300 dalton weight.
»
» I wouldn’t assume that the absortption of substances through tissues of
» the mouth follows the 500-Dalton rule, any more than I would assume that
» absorption of food across the intestinal lining (as in EATING FOOD the
» normal way) follows that same rule! :slight_smile:
»
» In other words, the 500-Dalton rule is a general rule-of-thumb for the
» likelihood of substances to pass through the SKIN specifically. I don’t
» know how relevant it is for anything else.
»
» .
Bryan, during the digestive process food is broken down with stomach acids and enzymes to a much smaller size, i.e. to their molecular size. Simple carbs for example have a low molecular size and instantanously enter the blood stream and complex are a much slower process because of their larger molecular size. Point is even in digestion size of the molecule matters. In addtion, the stomach lining is more condusive to penetration than the exterior dermis for a number of reasons. True the 500 dalton rule is a general rule of thumb, but when you go 2.5 times above that generally accepted rule of thumb your going to have problems with penetration compared to something with a dalton measurement closer to 500.

» Bryan, during the digestive process food is broken down with stomach acids
» and enzymes to a much smaller size, i.e. to their molecular size. Simple
» carbs for example have a low molecular size and instantanously enter the
» blood stream and complex are a much slower process because of their larger
» molecular size.

Actually, that’s rather misleading. Complex carbohydrates do have to be broken down into simple sugars before they can be absorbed, of course, but that takes place quite rapidly. In fact, starchy food like potatoes and pasta can have an even higher glycemic index than sucrose.

» Point is even in digestion size of the molecule matters. In
» addtion, the stomach lining is more condusive to penetration than the
» exterior dermis for a number of reasons.

Exactly!! Which is a major point here.

» True the 500 dalton rule is a
» general rule of thumb, but when you go 2.5 times above that generally
» accepted rule of thumb your going to have problems with penetration
» compared to something with a dalton measurement closer to 500.

But that general rule-of-thumb (500 Daltons) is for the SKIN, not for the digestive process. There may not be even so much as a remote connection (Dalton-wise) between those two processes.

.

Here is the text concerning dutasteride on wikipedia. Read the second paragraph for the relevant information related to Dutasteride’s clinical trial…

Dutasteride

In 2001, GlaxoSmithKline released another aza-steroid called dutasteride. Dutasteride is marketed as Avodart. Like finasteride, dutasteride was originally developed for the treatment of benign prostatic hyperplasia (BPH). While hair count studies showed that 2.5 mg of dutasteride was about 1.5 times as effective as finasteride for hair regrowth (adding on average 108 versus 72 hair per 1" diameter area), Glaxo stopped FDA hair loss studies after phase II. Although the exact reason was never made public, it was speculated that the product was too similar to finasteride, which itself had not lived up to expectations commercially. As such, the 2.5 mg dosage was not released. The FDA trials for BPH continued, and Avodart became the first drug shown to shrink an enlarged prostate in a clinical study. The .5mg version of the drug (shown in the same study to add on average 92 hairs to the same area) is increasingly available to hair loss sufferers via the grey-market of online prescription medication, and physicians increasingly willing to prescribe drugs “off-label.”

In December 2006, GlaxoSmithKline embarked on a new Phase III, six month study in Korea to test the safety, tolerability and effectiveness of a once-daily dose of dutasteride (0.5mg) for the treatment of male pattern baldness in the vertex region of the scalp (types IIIv, IV and V on the Hamilton-Norwood scale). [5] The future impact that this study will have on the FDA’s approval or disapproval of Avodart for the treatment of male pattern baldness in the United States is yet to be determined.

Here is the official link of GSK for the Clinical Trial

Does anybody here knows about the advancement of the phase 3 trial ?

thank you

One can’t help but wonder why they’re calling that a “Phase III” trial. How is it any different from the earlier trial done by Glaxo? :slight_smile:

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» One can’t help but wonder why they’re calling that a “Phase III” trial.
» How is it any different from the earlier trial done by Glaxo? :slight_smile:
»
» .

??? They only took the drug for alopecia through 2 trials and stop before the third even started.

» » One can’t help but wonder why they’re calling that a “Phase III” trial.
» » How is it any different from the earlier trial done by Glaxo? :slight_smile:
»
» ??? They only took the drug for alopecia through 2 trials and stop before
» the third even started.

You didn’t even adress the implicit question I asked, so I’ll go into a little more detail so that you can understand the point I’m making here:

Clinical medical trials aren’t referred to as “Phase 1” or “Phase 2” or “Phase 3” based simply on the order in which they appear! :slight_smile: There is a specific protocol which determines what kind of trial it is, and depends on factors like the size of the trial, how many test-subjects, the duration of the trial, and the specific objectives of the trial.

The earlier trial by Glaxo was properly described as a “Phase 2” trial, and lasted for six months. This new (alleged) Korean trial is also lasting for six months, and I’m pretty sure is using an even SMALLER number of test-subjects than the previous one. So again, my question is this: why is this (alleged) Korean trial being described as a “Phase 3” protocol, when it’s actually a SMALLER trial than the previous one?

.

» » » One can’t help but wonder why they’re calling that a “Phase III” trial.
»
» » » How is it any different from the earlier trial done by Glaxo? :slight_smile:
» »
» » ??? They only took the drug for alopecia through 2 trials and stop
» before
» » the third even started.
»
» You didn’t even adress the implicit question I asked, so I’ll go into a
» little more detail so that you can understand the point I’m making here:
»
» Clinical medical trials aren’t referred to as “Phase 1” or “Phase 2” or
» “Phase 3” based simply on the order in which they appear! :slight_smile: There is a
» specific protocol which determines what kind of trial it is, and
» depends on factors like the size of the trial, how many test-subjects, the
» duration of the trial, and the specific objectives of the trial.
»
» The earlier trial by Glaxo was properly described as a “Phase 2” trial,
» and lasted for six months. This new (alleged) Korean trial is also
» lasting for six months, and I’m pretty sure is using an even SMALLER
» number of test-subjects than the previous one. So again, my question is
» this: why is this (alleged) Korean trial being described as a “Phase 3”
» protocol, when it’s actually a SMALLER trial than the previous one?
»
» .

Bryan you don’t know what the FDA agreed to as far a phase 3 trial design. In addition, you are talking about a drug already approved for oral use. your wrong on this one.

» Bryan you don’t know what the FDA agreed to as far a phase 3 trial design.

Again, the alleged Korean trial is a SUBSET of the one that Glaxo already did before. Why would they have to do it again with an even SMALLER trial? :slight_smile:

» In addition, you are talking about a drug already approved for oral use.
» your wrong on this one.

It doesn’t make any difference that it’s already approved for oral use. It still has to be tested for any new indication (like MPB).

.

» » Bryan you don’t know what the FDA agreed to as far a phase 3 trial
» design.
»
» Again, the alleged Korean trial is a SUBSET of the one that Glaxo already
» did before. Why would they have to do it again with an even SMALLER
» trial? :slight_smile:
»
» » In addition, you are talking about a drug already approved for oral
» use.
» » your wrong on this one.
»
» It doesn’t make any difference that it’s already approved for oral use.
» It still has to be tested for any new indication (like MPB).
»
» .

Bryan, you don’t have to state the obvious. IT does matter that it has been apporved orally. IT can affect the trial design that the company and the FDA collaborate on.

» There has been some debate on whether or not the phase three trial for
» dutasteride is happening. I have confirmed the trial is happening, it is
» taking place in Korea. Should be interesting.

Why does that matter? We already know how well it does for hair loss. We had our own phase 3 trial in the forum years ago :slight_smile:

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