Skip to content

Bioequivalence study of vaginal progesterone suppository 400 mg

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

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
IRCT
Registry ID
IRCT20230222057495N4
Enrollment
24
Registered
2023-04-18
Start date
2023-04-04
Completion date
Unknown
Last updated
2023-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention 1: First intervention: Progesterone 400 mg vaginal suppositories manufactured by Ati Pharmed Pharmaceutical Company in Iran. Intervention 2: Second intervention: Progesterone 400 mg vagin

Sponsors

Ati Pharmed pharmaceutical company
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMonireh Jalalipour

Nik Azma Pars Alborz laboratory

info@naplab.ir+98 26 3731 8748

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026