1. Home
  2. Approved trials
  3. » فارسی

Bioequivalence study of vaginal progesterone suppository 400 mg of Ati Farmed pharmaceutical company compared to progesterone 400 sample manufactured by L.D. Collins&Co.,Ltd. England on healthy volunteers

Protocol summary

Study aim
The aim of these studies is to compare the absorption of two formulations of the same drug (vaginal progesterone suppository 400 mg).
Design
Bioequivalence studies (bioequivalence) of progesterone 400 mg vaginal suppositories manufactured by Ati Farmed pharmaceutical company compared to progesterone 400 manufactured by L.D. Collins&Co., Ltd., England includes in vivo tests after prescribing 24 healthy human volunteers with ethical approval and covered by liability insurance.
Settings and conduct
The study is conducted at Nik Azma Pars Alborz Company, located in Alborz Province, Mahdasht, Imam Khomeini Blvd., Azadegan Square, No. 419, Unit 3, which includes two stages (vaginal use of one 400 mg progesterone suppository in each study and in a total of 2 times) with a two-week washout period.
Participants/Inclusion and exclusion criteria
- A healthy non-pregnant and non-lactating female volunteer, who, while performing a pregnancy blood test before starting the study, ensures that the volunteers are not pregnant. - At the time of prescribing the drug, the volunteer should be on the 4-6th day of her menstrual cycle so that the amount of endogenous progesterone is at its minimum. - Age between 18 and 45 years. - The candidate's body mass index (BMI) must be less than 30 kg/m2. - Agree to take 10 ml of your blood for evaluation. - All candidates must be non-smokers.
Intervention groups
The study consists of two stages in the form of the first intervention: including the use of 400 mg progesterone vaginal suppositories manufactured by Ati Pharmed Pharmaceutical Company of Iran and the second intervention: consuming the 400 mg progesterone vaginal suppositories manufactured by L.D. Collins & Co., Ltd. The country is England, which is done with a time interval of 2 weeks as a washing time.
Main outcome variables
Drug plasma concentrations

General information

Reason for update
Acronym
BSVP
IRCT registration information
IRCT registration number: IRCT20230222057495N4
Registration date: 2023-04-18, 1402/01/29
Registration timing: registered_while_recruiting

Last update: 2023-04-18, 1402/01/29
Update count: 0
Registration date
2023-04-18, 1402/01/29
Registrant information
Name
Monireh Jalalipour
Name of organization / entity
Nikazma Pars Alborz company
Country
Iran (Islamic Republic of)
Phone
+98 26 3731 8748
Email address
info@naplab.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-04, 1402/01/15
Expected recruitment end date
2023-09-06, 1402/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Bioequivalence study of vaginal progesterone suppository 400 mg of Ati Farmed pharmaceutical company compared to progesterone 400 sample manufactured by L.D. Collins&Co.,Ltd. England on healthy volunteers
Public title
Bioequivalence study of vaginal progesterone suppository 400 mg
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
A healthy, non-pregnant and non-lactating female volunteer, who at the time of drug administration should be on the 4th-6th day of her menstrual cycle so that the amount of endogenous progesterone is at its minimum. Be between 18 and 45 years old. All candidates must be non-smokers. Candidate's body mass index (BMI) should be less than 30 kg/m2.
Exclusion criteria:
Blood pressure lower than 90/60 mm Hg or higher than 140/90 mm Hg Smokers who use more than 10 cigarettes a day Consumption of any drugs, alcohol or tobacco products within 2 weeks before receiving the drug
Age
From 18 years old to 45 years old
Gender
Female
Phase
Bioequivalence
Groups that have been masked
No information
Sample size
Target sample size: 24
More than 1 sample in each individual
Number of samples in each individual: 36
n each sample, 5 cc of blood is taken from the participant at 18 time intervals. And this process is repeated twice (totally 36 samples from each person).
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Institute of Pharmaceutical Sciences, Tehran University of Medical Sciences
Street address
Porsina Street, Tehran University of Medical Sciences, Faculty of Pharmacy, Institute of Pharmaceutical Sciences
City
Tehran
Province
Tehran
Postal code
1417613151
Approval date
2023-03-12, 1401/12/21
Ethics committee reference number
IR.TUMS.TIPS.REC.1401.138

Health conditions studied

1

Description of health condition studied
---
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Cmax
Timepoint
Once 15 minutes before the start of drug administration and then at time intervals: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 30, 48, 56 and 72 hours after administration. , will be done
Method of measurement
HPLC with UV detector

Secondary outcomes

empty

Intervention groups

1

Description
First intervention: Progesterone 400 mg vaginal suppositories manufactured by Ati Pharmed Pharmaceutical Company in Iran
Category
Other

2

Description
Second intervention: Progesterone 400 mg vaginal suppositories manufactured by L.D. Collins & Co., Ltd. England
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Nik Azma Pars Alborz laboratory
Full name of responsible person
Monireh Jalalipour
Street address
No. 419, Imam Khomeini Boulevard, Azadegan Square
City
Mahdasht Karaj
Province
Alborz
Postal code
3188913179
Phone
+98 26 3731 8748
Email
info@naplab.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ati Pharmed pharmaceutical company
Full name of responsible person
‌Behnaz Moghaddam
Street address
Corner of 16 St. Bucharest, Sahand Building, No. 41, 4th floor, unit
City
Tehran
Province
Tehran
Postal code
۱۵۱۴۸۳۳۱۳۹
Phone
+98 21 8876 2210
Email
info@atipharmed.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ati Pharmed pharmaceutical company
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry

Person responsible for general inquiries

Contact
Name of organization / entity
Nik Azma Pars Alborz laboratory
Full name of responsible person
Monireh Jalalipour
Position
Responsible Pharmacist
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No. 419, Imam Khomeini Boulevard, Azadegan Square
City
Mahdasht Karaj
Province
Alborz
Postal code
3188913179
Phone
+98 26 3731 8748
Email
info@naplab.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Nik Azma Pars Alborz laboratory
Full name of responsible person
Monireh Jalalipour
Position
Responsible Pharmacist
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No. 419, Imam Khomeini Boulevard, Azadegan Square
City
Mahdasht Karaj
Province
Alborz
Postal code
3188913179
Phone
+98 26 3731 8748
Email
info@naplab.ir

Person responsible for updating data

Contact
Name of organization / entity
Nik Azma Pars Alborz laboratory
Full name of responsible person
Monireh Jalalipour
Position
Responsible Pharmacist
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No. 419, Imam Khomeini Boulevard, Azadegan Square
City
Mahdasht Karaj
Province
Alborz
Postal code
3188913179
Phone
+98 26 3731 8748
Email
info@naplab.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Loading...