Ignite Creation Date:
2024-05-05 @ 9:56 PM
Last Modification Date:
2024-10-26 @ 10:11 AM
Study NCT ID:
NCT00992329
Status:
COMPLETED
Last Update Posted:
2020-11-06
First Post:
2009-10-02
Brief Title:
Impact of Formulation on Ciprofloxacin Oral Absorption
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Impact of Formulation on Ciprofloxacin Oral Absorption
Status:
COMPLETED
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this research is to see if certain tablet formulation factors affect oral drug absorption Medications taken by mouth such as tablets need to be absorbed into the body in order to do any good Tablets contain a drug but also contain non-drug ingredients that are called excipients or fillers Excipients in the tablet and the way in which the tablet is manufactured both can impact how much drug is absorbed into the body That is tablet formulation factors can cause a tablet to be effective or not effective
Tablets in this research contain the drug ciprofloxacin hydrochloride Ciprofloxacin is an antibiotic to treat infections such as lung infections This drug is being used since it has low water solubility and is probably sensitive to tablet formulation factors
Tablets in this research contain the drug ciprofloxacin hydrochloride Ciprofloxacin is an antibiotic to treat infections such as lung infections This drug is being used since it has low water solubility and is probably sensitive to tablet formulation factors
Detailed Description:
Dogs and humans exhibit differences in gastrointestinal physiology The development of pharmaceuticals for both humans and dogs typically depends upon pharmacokinetic studies in the other species Product design and quality attributes for dogs and for humansgenerally conduct such extrapolations in a simplistic fashion without a systematic account of the differential intestinal physiology between dog and human This project aims to elucidate product quality differences between human and dog oral solid dosage forms as a result of the differential physiology between the two specifies This insight will facilitate the regulation of canine medicines by highlighting how product standards for human medicines are either too liberal or too restrictive for canine medicines
Ciprofloxacin hydrochloride will be used as a model poorly soluble drug A range of immediate-release IR tablets will be formulated to map the design space Formulations will be fast medium and slow with respect to dissolution rate of drug Ciprofloxacin is expected to exhibit formulation-dependent pharmacokinetics which is additionally impacted by the differential physiology between dog and humans In particular the investigators anticipate a greater sensitivity to formulation for dogs than for humans Consequently the investigators anticipate dogs to be more sensitive to formulations where such critical formulation factors must be considered in canine product design and regulation
Objectives 1 The primary objective of this human study is to assess whether specific formulation factors impact the rate and extent of ciprofloxacin oral absorption as well as the absolute absorption profile of ciprofloxacin 2 The secondary objective is to assess if dogs exhibit a greater sensitivity to formulation than do humans
Hypotheses The investigators anticipate that humans exhibit a modest sensitivity to specific tablet formulation factors 1 Hence the hypothesis of this human study is that humans do not exhibit a sensitivity to specific formulation factors and show no in vitro - in vivo correlation to dissolution rate 2 Alternative hypothesis is that humans do exhibit a sensitivity to specific formulation factors and show an in vitro - in vivo correlation to dissolution rate
Ciprofloxacin hydrochloride will be used as a model poorly soluble drug A range of immediate-release IR tablets will be formulated to map the design space Formulations will be fast medium and slow with respect to dissolution rate of drug Ciprofloxacin is expected to exhibit formulation-dependent pharmacokinetics which is additionally impacted by the differential physiology between dog and humans In particular the investigators anticipate a greater sensitivity to formulation for dogs than for humans Consequently the investigators anticipate dogs to be more sensitive to formulations where such critical formulation factors must be considered in canine product design and regulation
Objectives 1 The primary objective of this human study is to assess whether specific formulation factors impact the rate and extent of ciprofloxacin oral absorption as well as the absolute absorption profile of ciprofloxacin 2 The secondary objective is to assess if dogs exhibit a greater sensitivity to formulation than do humans
Hypotheses The investigators anticipate that humans exhibit a modest sensitivity to specific tablet formulation factors 1 Hence the hypothesis of this human study is that humans do not exhibit a sensitivity to specific formulation factors and show no in vitro - in vivo correlation to dissolution rate 2 Alternative hypothesis is that humans do exhibit a sensitivity to specific formulation factors and show an in vitro - in vivo correlation to dissolution rate
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HHSF223200810030C | OTHER_GRANT | DHHS | None |