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A Comparative Bioavailability Study of DFD-29 Capsules 40 mg Versus SOLODYN® Tablets 105 mg, Under Fasting & Fed Conditions in Healthy Adult Human Subjects

NCT05452785 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-03-02

No results posted yet for this study

Summary

Single-center, randomized, open-label, laboratory-blinded, 3-treatment, 3-period, 6-sequence, single-dose, crossover study.

Conditions

  • Pharmacokinetics

Interventions

DRUG

DFD-29 (Minocycline) Fasting

In each study period, a single 40 mg dose of DFD-29 Capsules will be administered orally with approximately 240 mL of water, in the morning, following a 10-hour overnight fast.

DRUG

DFD-29 (Minocycline) Fed

In each study period, a single 40 mg dose of DFD-29 Capsules will be administered orally with approximately 240 mL of water, in the morning, following a 10-hour overnight fast and 30 minutes after the start of a high-fat, high-calorie breakfast.

DRUG

Solodyn (Minocycline) Fasting

In each study period, a single 105 mg dose of SOLODYN® Tablets will be administered orally with approximately 240 mL of water, in the morning, following a 10-hour overnight fast.

Sponsors & Collaborators

  • Dr. Reddy's Laboratories Limited

    collaborator INDUSTRY

  • Journey Medical Corporation

    lead INDUSTRY

Principal Investigators

  • Srinivas R Sidgiddi, M.D. · Journey Medical Corporation

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-07
Primary Completion
2022-05-25
Completion
2022-05-25
FDA Drug
Yes

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05452785 on ClinicalTrials.gov